Surgical hub having variable interconnectivity capabilities

ABSTRACT

A surgical hub may obtain a hub connectivity mode based on a hub connectivity control parameter. For example, the hub connectivity mode may be selected from multiple connectivity modes that may be preconfigured, dynamically updated, semi-dynamically updated, periodically updated, or preset. The hub connectivity modes may control inter-device connectivity within a network associated with a hospital, and/or communication with an external network associated with a different hospital. The surgical hub may determine whether to provide instructional information to at least one smart surgical instrument based on the hub connectivity mode. On a condition that the hub connectivity mode does not support provisioning instructional information to surgical devices, provisioning instructional information to surgical devices may be disabled. On a condition that the hub connectivity mode supports provisioning instructional information to surgical devices, the surgical hub may determine to obtain and provide instructional information to surgical devices.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to an application filed contemporaneously,with Attorney Docket No. END9287USNP1, entitled METHOD FOR OPERATINGTIERED OPERATION MODES IN A SURGICAL SYSTEM, the contents of which isincorporated by reference herein.

BACKGROUND

Surgical systems often incorporate an imaging system, which can allowthe clinician(s) to view the surgical site and/or one or more portionsthereof on one or more displays such as a monitor, for example. Thedisplay(s) can be local and/or remote to a surgical theater. An imagingsystem can include a scope with a camera that views the surgical siteand transmits the view to a display that is viewable by a clinician.Scopes include, but are not limited to, arthroscopes, angioscopes,bronchoscopes, choledochoscopes, colonoscopes, cytoscopes,duodenoscopes, enteroscopes, esophagogastro-duodenoscopes(gastroscopes), endoscopes, laryngoscopes, nasopharyngo-neproscopes,sigmoidoscopes, thoracoscopes, ureteroscopes, and exoscopes. Imagingsystems can be limited by the information that they are able torecognize and/or convey to the clinician(s). For example, certainconcealed structures, physical contours, and/or dimensions within athree-dimensional space may be unrecognizable intraoperatively bycertain imaging systems. Additionally, certain imaging systems may beincapable of communicating and/or conveying certain information to theclinician(s) intraoperatively.

SUMMARY

A surgical hub may be connected, wired or wireless, with various devicesand servers in the operating room, in the medical facility and/oroutside of the medical facility. The surgical hub may determine the hubconnectivity mode based on a hub connectivity control parameter. The hubconnectivity mode may be selected from multiple connectivity modes thatmay be preconfigured, dynamically updated, semi-dynamically updated,periodically updated, or preset. The hub connectivity modes may controlinter-device connectivity within a network associated with a hospital,and/or communication with an external network associated with adifferent hospital, for example.

For example, the surgical hub may determine whether to disable obtaininginstructional information based on the connectivity mode. Based on adetermination that the current connectivity mode is a flow-through mode,the surgical hub may disable obtaining instructional information.

For example, the surgical hub may determine whether to provideinstructional information to at least one smart surgical instrumentbased on the hub connectivity mode. On a condition that the hubconnectivity mode does not support provisioning instructionalinformation to surgical devices, provisioning instructional informationto surgical devices may be disabled. On a condition that the hubconnectivity mode supports provisioning instructional information tosurgical devices, the surgical hub may determine to obtain and provideinstructional information to surgical devices.

For example, the surgical hub may determine whether to retrieveaggregation analysis from the remote server based on the hubconnectivity mode. Based on a determination that the current hubconnectivity mode supports remote data aggregation and analysis, thesurgical hub may generate an aggregation analysis request. The requestmay be generated based on the received surgical data and may be sent toa remote server. For example, the aggregation analysis request mayindicate a request for recommendation on generator data associated witha particular step in a surgical procedure. In response, the surgical hubmay receive an aggregation analysis response from the remote server. Forexample, the aggregation analysis response may include a recommendationand/or a report. The aggregation analysis response may include one ormore of: an energy mode of the generator for a particular surgicalprocedure, a power output of the generator for a particular surgicalprocedure, and/or a duration of the power output of the generator for aparticular surgical procedure. The aggregation analysis response mayinclude instructional information as described herein. The surgical hubmay generate and send instructional information to one or more surgicaldevice(s) based on the received aggregation analysis response. Based ona determination that the current hub connectivity mode supports remotedata aggregation analysis, the surgical hub may disable data aggregationanalysis requests.

The hub connectivity control parameter(s) may include, but not limitedto, systems capabilities such as hardware capability, firmwarecapability and/or software capability. The hub connectivity controlparameter(s) may include a consumer-controlled parameter, such as asubscription level. For example, a medical facility may purchase asubscription to hub connectivity capabilities. Some subscriptionlevel(s) may provide the hub access to surgical data gathered fromexternal systems, while others may limit the hub connectivity tointernal devices.

In an example hub connectivity mode, the surgical hub may receiveinformation from surgical instrument(s) and may send the receivedinformation to a remote server (such as a remote processing serverand/or a remote database in the cloud).

In an example connectivity mode, the surgical hub may receiveinformation from surgical instrument(s) and may send the receivedinformation to a remote server (such as a remote processing serverand/or a remote database in the cloud). The surgical hub may receiveinformation from surgical instrument(s), obtain instructionalinformation based on the information received from the surgicalinstrument(s), and may send the instructional information to one or moresurgical instrument(s).

In an example connectivity mode, the surgical hub may receiveinformation from surgical instrument(s) and may send the receivedinformation to a remote server (such as a remote processing serverand/or a remote database in the cloud). The surgical hub may receiveinformation from surgical instrument(s), obtain instructionalinformation based on the information received from the surgicalinstrument(s), and may send the instructional information to one or moresurgical instrument(s). The surgical hub may record various surgicalinformation and send surgical information to a remote server forarchiving and/or analysis. The archived surgical information may beaggregated with information received from other surgical hub(s), and/orsurgical information associated with other medical facilities. Theaggregated information may be accessed to generate instructionalinformation to one or more surgical instrument(s). In an example, thesurgical communication hub may aggregate information, such asinformation received from smart surgical devices, information associatedwith multiple surgeries, surgical information and corresponding outcomeassociated with multiple patients. The aggregated information may bestored in a remote database. In an example, the surgical information maybe aggregated at a remote server.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 2 is a surgical system being used to perform a surgical procedurein an operating room, in accordance with at least one aspect of thepresent disclosure.

FIG. 3 is a surgical hub paired with a visualization system, a roboticsystem, and an intelligent instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 4 illustrates a surgical data network comprising a modularcommunication hub configured to connect modular devices located in oneor more operating theaters of a healthcare facility, or any room in ahealthcare facility specially equipped for surgical operations, to thecloud, in accordance with at least one aspect of the present disclosure.

FIG. 5 illustrates a computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 6 illustrates a surgical hub comprising a plurality of modulescoupled ho the modular control tower, in accordance with at least oneaspect of the present disclosure.

FIG. 7 illustrates a logic diagram of a control system of a surgicalinstrument or tool, in accordance with at least one aspect of thepresent disclosure.

FIG. 8 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions, inaccordance with at least one aspect of the present disclosure.

FIG. 9 illustrates a diagram of a situationally aware surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 10 illustrates a timeline of an illustrative surgical procedure andthe inferences that the surgical hub can make from the data detected ateach step in the surgical procedure, in accordance with at least oneaspect of the present disclosure.

FIG. 11 is a block diagram of the computer-implemented interactivesurgical system, in accordance with at least one aspect of the presentdisclosure.

FIG. 12 is a block diagram which illustrates the functional architectureof the computer-implemented interactive surgical system, in accordancewith at least one aspect of the present disclosure.

FIG. 13 illustrates a block diagram of a computer-implementedinteractive surgical system that is configured to adaptively generatecontrol program updates for modular devices, in accordance with at leastone aspect of the present disclosure.

FIG. 14 illustrates a surgical system that includes a handle having acontroller and a motor, an adapter releasably coupled to the handle, anda loading unit releasably coupled to the adapter, in accordance with atleast one aspect of the present disclosure.

FIG. 15A illustrates an example flow for determining a mode of operationand operating in the determined mode, in accordance with at least oneaspect of the present disclosure.

FIG. 15B illustrates an example flow for changing a mode of operation,in accordance with at least one aspect of the present disclosure.

FIGS. 16A-C illustrate example hub connectivity modes.

FIG. 17 shows an example flow for operating under tiered hubcommunication modes.

FIGS. 18A-C show example flows for operating under tiered hubcommunication modes.

FIG. 19 illustrates an example interactive surgical system, inaccordance with at least one aspect of the present disclosure.

FIG. 20 illustrates an example surgical supply packaged with an RFID NFCchip.

DETAILED DESCRIPTION

Applicant of the present application owns the following U.S. patentapplications, each of which is herein incorporated by reference in itsentirety:

-   U.S. patent application Ser. No. 15/940,654 (Attorney Docket No.    END8501USNP), entitled SURGICAL HUB SITUATIONAL AWARENESS, filed    Mar. 29, 2018;-   U.S. patent application Ser. No. 15/940,668 titled AGGREGATION AND    REPORTING OF SURGICAL HUB DATA; Attorney Docket No. END8501USNP2,    filed on Mar. 29, 2018;-   U.S. patent application Ser. No. 16/209,478 (Attorney Docket No.    END9015USNP1), entitled METHOD FOR SITUATIONAL AWARENESS FOR    SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE CAPABLE OF    ADJUSTING FUNCTION BASED ON A SENSED SITUATION OR USAGE, filed Dec.    4, 2018;-   U.S. patent application Ser. No. 16/182,246 (Attorney Docket No.    END9016USNP1), entitled ADJUSTMENTS BASED ON AIRBORNE PARTICLE    PROPERTIES, filed Nov. 6, 2018; and-   U.S. patent application Ser. No. 16/209,385 (Attorney Docket No.    END8495USNP), titled METHOD OF HUB COMMUNICATION, PROCESSING,    STORAGE AND DISPLAY, filed Dec. 4, 2018.

Referring to FIG. 1, a computer-implemented interactive surgical system100 may include one or more surgical systems 102 and a cloud-basedsystem (e.g., the cloud 104 that may include a remote server 113 coupledto a storage device 105). Each surgical system 102 may include at leastone surgical hub 106 in communication with the cloud 104 that mayinclude a remote server 113. In one example, as illustrated in FIG. 1,the surgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or the hub 106. Insome aspects, a surgical system 102 may include an M number of hubs 106,an N number of visualization systems 108, an O number of robotic systems110, and a P number of handheld intelligent surgical instruments 112,where M, N, O, and P may be integers greater than or equal to one.

In various aspects, the visualization system 108 may include one or moreimaging sensors, one or more image-processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2. In one aspect,the visualization system 108 may include an interface for HL7, PACS, andEMR. Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S. PatentApplication Publication No. US 2019-0200844 A1 (U.S. patent applicationSer. No. 16/209,385), titled METHOD OF HUB COMMUNICATION, PROCESSING,STORAGE AND DISPLAY, filed Dec. 4, 2018, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2, a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 may include a first non-steriledisplay 107 and a second non-sterile display 109, which face away fromeach other. The visualization system 108, guided by the hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, the hub 106 may cause the visualization system 108 to display asnapshot of a surgical site, as recorded by an imaging device 124, on anon-sterile display 107 or 109, while maintaining a live feed of thesurgical site on the primary display 119. The snapshot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, the hub 106 may also be configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snapshotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary display 119 by the hub 106.

Referring to FIG. 2, a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. The hub 106 mayalso be configured to coordinate information flow to a display of thesurgical instrument 112. For example, in U.S. Patent ApplicationPublication No. US 2019-0200844 A1 (U.S. patent application Ser. No.16/209,385), titled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE ANDDISPLAY, filed Dec. 4, 2018, the disclosure of which is hereinincorporated by reference in its entirety. A diagnostic input orfeedback entered by a non-sterile operator at the visualization tower111 can be routed by the hub 106 to the surgical instrument display 115within the sterile field, where it can be viewed by the operator of thesurgical instrument 112. Example surgical instruments that are suitablefor use with the surgical system 102 are described under the heading“Surgical Instrument Hardware” and in U.S. Patent ApplicationPublication No. US 2019-0200844 A1 (U.S. patent application Ser. No.16/209,385), titled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE ANDDISPLAY, filed Dec. 4, 2018, the disclosure of which is hereinincorporated by reference in its entirety, for example.

FIG. 2 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. A robotic system 110 may beused in the surgical procedure as a part of the surgical system 102. Therobotic system 110 may include a surgeon's console 118, a patient sidecart 120 (surgical robot), and a surgical robotic hub 122. The patientside cart 120 can manipulate at least one removably coupled surgicaltool 117 through a minimally invasive incision in the body of thepatient while the surgeon views the surgical site through the surgeon'sconsole 118. An image of the surgical site can be obtained by a medicalimaging device 124, which can be manipulated by the patient side cart120 to orient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Patent Application Publication No. US 2019-0201137 A1(U.S. patent application Ser. No. 16/209,407), titled METHOD OF ROBOTICHUB COMMUNICATION, DETECTION, AND CONTROL, filed Dec. 4, 2018, thedisclosure of which is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Patent Application Publication No. US 2019-0206569 A1(U.S. patent application Ser. No. 16/209,403), titled METHOD OF CLOUDBASED DATA ANALYTICS FOR USE WITH THE HUB, filed Dec. 4, 2018, thedisclosure of which is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 may include at least oneimage sensor and one or more optical components. Suitable image sensorsmay include, but are not limited to, Charge-Coupled Device (CCD) sensorsand Complementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (e.g., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

The imaging device may employ multi-spectrum monitoring to discriminatetopography and underlying structures. A multi-spectral image is one thatcaptures image data within specific wavelength ranges across theelectromagnetic spectrum. The wavelengths may be separated by filters orby the use of instruments that are sensitive to particular wavelengths,including light from frequencies beyond the visible light range, e.g.,IR and ultraviolet. Spectral imaging can allow extraction of additionalinformation the human eye fails to capture with its receptors for red,green, and blue. The use of multi-spectral imaging is described ingreater detail under the heading “Advanced Imaging Acquisition Module”in U.S. Patent Application Publication No. US 2019-0200844 A1 (U.S.patent application Ser. No. 16/209,385), titled METHOD OF HUBCOMMUNICATION, PROCESSING, STORAGE AND DISPLAY, filed Dec. 4, 2018, thedisclosure of which is herein incorporated by reference in its entirety.Multi-spectrum monitoring can be a useful tool in relocating a surgicalfield after a surgical task is completed to perform one or more of thepreviously described tests on the treated tissue. It is axiomatic thatstrict sterilization of the operating room and surgical equipment isrequired during any surgery. The strict hygiene and sterilizationconditions required in a “surgical theater,” i.e., an operating ortreatment room, necessitate the highest possible sterility of allmedical devices and equipment. Part of that sterilization process is theneed to sterilize anything that comes in contact with the patient orpenetrates the sterile field, including the imaging device 124 and itsattachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

Referring now to FIG. 3, a hub 106 is depicted in communication with avisualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. The hub 106 includes a hub display135, an imaging module 138, a generator module 140, a communicationmodule 130, a processor module 132, a storage array 134, and anoperating-room mapping module 133. In certain aspects, as illustrated inFIG. 3, the hub 106 further includes a smoke evacuation module 126and/or a suction/irrigation module 128. During a surgical procedure,energy application to tissue, for sealing and/or cutting, is generallyassociated with smoke evacuation, suction of excess fluid, and/orirrigation of the tissue. Fluid, power, and/or data lines from differentsources are often entangled during the surgical procedure. Valuable timecan be lost addressing this issue during a surgical procedure.Detangling the lines may necessitate disconnecting the lines from theirrespective modules, which may require resetting the modules. The hubmodular enclosure 136 offers a unified environment for managing thepower, data, and fluid lines, which reduces the frequency ofentanglement between such lines. Aspects of the present disclosurepresent a surgical hub for use in a surgical procedure that involvesenergy application to tissue at a surgical site. The surgical hubincludes a hub enclosure and a combo generator module slidablyreceivable in a docking station of the hub enclosure. The dockingstation includes data and power contacts. The combo generator moduleincludes two or more of an ultrasonic energy generator component, abipolar RF energy generator component, and a monopolar RF energygenerator component that are housed in a single unit. In one aspect, thecombo generator module also includes a smoke evacuation component, atleast one energy delivery cable for connecting the combo generatormodule to a surgical instrument, at least one smoke evacuation componentconfigured to evacuate smoke, fluid, and/or particulates generated bythe application of therapeutic energy to the tissue, and a fluid lineextending from the remote surgical site to the smoke evacuationcomponent. In one aspect, the fluid line is a first fluid line and asecond fluid line extends from the remote surgical site to a suction andirrigation module slidably received in the hub enclosure. In one aspect,the hub enclosure comprises a fluid interface. Certain surgicalprocedures may require the application of more than one energy type tothe tissue. One energy type may be more beneficial for cutting thetissue, while another different energy type may be more beneficial forsealing the tissue. For example, a bipolar generator can be used to sealthe tissue while an ultrasonic generator can be used to cut the sealedtissue. Aspects of the present disclosure present a solution where a hubmodular enclosure 136 is configured to accommodate different generators,and facilitate an interactive communication therebetween. One of theadvantages of the hub modular enclosure 136 is enabling the quickremoval and/or replacement of various modules. Aspects of the presentdisclosure present a modular surgical enclosure for use in a surgicalprocedure that involves energy application to tissue. The modularsurgical enclosure includes a first energy-generator module, configuredto generate a first energy for application to the tissue, and a firstdocking station comprising a first docking port that includes first dataand power contacts, wherein the first energy-generator module isslidably movable into an electrical engagement with the power and datacontacts and wherein the first energy-generator module is slidablymovable out of the electrical engagement with the first power and datacontacts. Further to the above, the modular surgical enclosure alsoincludes a second energy-generator module configured to generate asecond energy, different than the first energy, for application to thetissue, and a second docking station comprising a second docking portthat includes second data and power contacts, wherein the secondenergy-generator module is slidably movable into an electricalengagement with the power and data contacts, and wherein the secondenergy-generator module is slidably movable out of the electricalengagement with the second power and data contacts. In addition, themodular surgical enclosure also includes a communication bus between thefirst docking port and the second docking port, configured to facilitatecommunication between the first energy-generator module and the secondenergy-generator module. Referring to FIG. 3, aspects of the presentdisclosure are presented for a hub modular enclosure 136 that allows themodular integration of a generator module 140, a smoke evacuation module126, and a suction/irrigation module 128. The hub modular enclosure 136further facilitates interactive communication between the modules 140,126, 128. The generator module 140 can be a generator module withintegrated monopolar, bipolar, and ultrasonic components supported in asingle housing unit slidably insertable into the hub modular enclosure136. The generator module 140 can be configured to connect to amonopolar device 142, a bipolar device 144, and an ultrasonic device146. Alternatively, the generator module 140 may comprise a series ofmonopolar, bipolar, and/or ultrasonic generator modules that interactthrough the hub modular enclosure 136. The hub modular enclosure 136 canbe configured to facilitate the insertion of multiple generators andinteractive communication between the generators docked into the hubmodular enclosure 136 so that the generators would act as a singlegenerator.

FIG. 4 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to acloud-based system (e.g., the cloud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network serves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switch(es), and network router(s) connectingthe devices 1 a-1 n/2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/2 a-2 m coupled to the network hub or network switch maycollect data in real time and transfer the data to cloud computers fordata processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services—such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a fixed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovider. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. The hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices 1 a-1 n/2 a-2 m, the surgical data network can provideimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue sealing and cutting procedure. At least some ofthe devices 1 a-1 n/2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This may include localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/2 a-2 m may be employedto identify anatomical structures of the body using a variety of sensorsintegrated with imaging devices and techniques such as overlaying imagescaptured by multiple imaging devices. The data gathered by the devices 1a-1 n/2 a-2 m, including image data, may be transferred to the cloud 204or the local computer system 210 or both for data processing andmanipulation including image processing and manipulation. The data maybe analyzed to improve surgical procedure outcomes by determining iffurther treatment, such as the application of endoscopic intervention,emerging technologies, a targeted radiation, targeted intervention, andprecise robotics to tissue-specific sites and conditions, may bepursued. Such data analysis may further employ outcome analyticsprocessing, and using standardized approaches may provide beneficialfeedback to either confirm surgical treatments and the behavior of thesurgeon or suggest modifications to surgical treatments and the behaviorof the surgeon.

The operating theater devices 1 a-1 n may be connected to the modularcommunication hub 203 over a wired channel or a wireless channeldepending on the configuration of the devices 1 a-1 n to a network hub.The network hub 207 may be implemented, in one aspect, as a localnetwork broadcast device that works on the physical layer of the OpenSystem Interconnection (OSI) model. The network hub may provideconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 may collect data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 may not store any media access control/Internet Protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207may not have routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 4) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

The operating theater devices 2 a-2 m may be connected to a networkswitch 209 over a wired channel or a wireless channel. The networkswitch 209 works in the data link layer of the OSI model. The networkswitch 209 may be a multicast device for connecting the devices 2 a-2 mlocated in the same operating theater to the network. The network switch209 may send data in the form of frames to the network router 211 andworks in full duplex mode. Multiple devices 2 a-2 m can send data at thesame time through the network switch 209. The network switch 209 storesand uses MAC addresses of the devices 2 a-2 m to transfer data.

The network hub 207 and/or the network switch 209 may be coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network layer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 211 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 may send data in the form of packets to the cloud 204 andworks in full duplex mode. Multiple devices can send data at the sametime. The network router 211 uses IP addresses to transfer data.

In an example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In examples, the operating theater devices 1 a-1 n/2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). The operating theater devices 1 a-1 n/2 a-2 m may communicate tothe modular communication hub 203 via a number of wireless or wiredcommunication standards or protocols, including but not limited to Wi-Fi(IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, new radio(NR), long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE,GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivatives thereof, as wellas any other wireless and wired protocols that are designated as 3G, 4G,5G, and beyond. The computing module may include a plurality ofcommunication modules. For instance, a first communication module may bededicated to shorter-range wireless communications such as Wi-Fi andBluetooth, and a second communication module may be dedicated tolonger-range wireless communications such as GPS, EDGE, GPRS, CDMA,WiMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/2 a-2 m and mayhandle a data type known as frames. Frames may carry the data generatedby the devices 1 a-1 n/2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 can be generally easyto install, configure, and maintain, making it a good option fornetworking the operating theater devices 1 a-1 n/2 a-2 m.

FIG. 5 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote server 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown in FIG. 6, the modularcontrol tower 236 comprises a modular communication hub 203 coupled to acomputer system 210.

As illustrated in the example of FIG. 5, the modular control tower 236may be coupled to an imaging module 238 that may be coupled to anendoscope 239, a generator module 240 that may be coupled to an energydevice 241, a smoke evacuator module 226, a suction/irrigation module228, a communication module 230, a processor module 232, a storage array234, a smart device/instrument 235 optionally coupled to a display 237,and a non-contact sensor module 242. The operating theater devices maybe coupled to cloud computing resources and data storage via the modularcontrol tower 236. A robot hub 222 also may be connected to the modularcontrol tower 236 and to the cloud computing resources. Thedevices/instruments 235, visualization systems 208, among others, may becoupled to the modular control tower 236 via wired or wirelesscommunication standards or protocols, as described herein. The modularcontrol tower 236 may be coupled to a hub display 215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

FIG. 6 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control tower 236may comprise a modular communication hub 203, e.g., a networkconnectivity device, and a computer system 210 to provide localprocessing, visualization, and imaging, for example. As shown in FIG. 6,the modular communication hub 203 may be connected in a tieredconfiguration to expand the number of modules (e.g., devices) that maybe connected to the modular communication hub 203 and transfer dataassociated with the modules to the computer system 210, cloud computingresources, or both. As shown in FIG. 6, each of the networkhubs/switches in the modular communication hub 203 may include threedownstream ports and one upstream port. The upstream network hub/switchmay be connected to a processor to provide a communication connection tothe cloud computing resources and a local display 217. Communication tothe cloud 204 may be made either through a wired or a wirelesscommunication channel.

The surgical hub 206 may employ a non-contact sensor module 242 tomeasure the dimensions of the operating theater and generate a map ofthe surgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module mayscan the operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in U.S. Patent ApplicationPublication No. US 2019-0200844 A1 (U.S. patent application Ser. No.16/209,385), titled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE ANDDISPLAY, filed Dec. 4, 2018, which is herein incorporated by referencein its entirety, in which the sensor module is configured to determinethe size of the operating theater and to adjust Bluetooth-pairingdistance limits. A laser-based non-contact sensor module may scan theoperating theater by transmitting laser light pulses, receiving laserlight pulses that bounce off the perimeter walls of the operatingtheater, and comparing the phase of the transmitted pulse to thereceived pulse to determine the size of the operating theater and toadjust Bluetooth pairing distance limits, for example.

The computer system 210 may comprise a processor 244 and a networkinterface 245. The processor 244 can be coupled to a communicationmodule 247, storage 248, memory 249, non-volatile memory 250, andinput/output interface 251 via a system bus. The system bus can be anyof several types of bus structure(s) including the memory bus or memorycontroller, a peripheral bus or external bus, and/or a local bus usingany variety of available bus architectures including, but not limitedto, 9-bit bus, Industrial Standard Architecture (ISA), Micro-CharmelArchitecture (MSA), Extended ISA (EISA), Intelligent Drive Electronics(IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI),USB, Advanced Graphics Port (AGP), Personal Computer Memory CardInternational Association bus (PCMCIA), Small Computer Systems Interface(SCSI), or any other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory may include volatile memory and non-volatile memory.The basic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during start-up, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and directRambus RAM (DRRAM).

The computer system 210 also may include removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage can include, but is not limited to, deviceslike a magnetic disk drive, floppy disk drive, tape drive, Jaz drive,Zip drive, LS-60 drive, flash memory card, or memory stick. In addition,the disk storage can include storage media separately or in combinationwith other storage media including, but not limited to, an optical discdrive such as a compact disc ROM device (CD-ROM), compact discrecordable drive (CD-R Drive), compact disc rewritable drive (CD-RWDrive), or a digital versatile disc ROM drive (DVD-ROM). To facilitatethe connection of the disk storage devices to the system bus, aremovable or non-removable interface may be employed.

It is to be appreciated that the computer system 210 may includesoftware that acts as an intermediary between users and the basiccomputer resources described in a suitable operating environment. Suchsoftware may include an operating system. The operating system, whichcan be stored on the disk storage, may act to control and allocateresources of the computer system. System applications may take advantageof the management of resources by the operating system through programmodules and program data stored either in the system memory or on thedisk storage. It is to be appreciated that various components describedherein can be implemented with various operating systems or combinationsof operating systems.

A user may enter commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices may include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter may be provided to illustrate that there can be some outputdevices like monitors, displays, speakers, and printers, among otheroutput devices that may require special adapters. The output adaptersmay include, by way of illustration and not limitation, video and soundcards that provide a means of connection between the output device andthe system bus. It should be noted that other devices and/or systems ofdevices, such as remote computer(s), may provide both input and outputcapabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, server, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) may be logically connected to the computer systemthrough a network interface and then physically connected via acommunication connection. The network interface may encompasscommunication networks such as local area networks (LANs) and wide areanetworks (WANs). LAN technologies may include Fiber Distributed DataInterface (FDDI), Copper Distributed Data Interface (CDDI),Ethernet/IEEE 802.3, Token Ring/IEEE 802.5 and the like. WANtechnologies may include, but are not limited to, point-to-point links,circuit-switching networks like Integrated Services Digital Networks(ISDN) and variations thereon, packet-switching networks, and DigitalSubscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 6, the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 5-6, may comprise an image processor, image-processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (SIMD)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image-processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) may refer to the hardware/softwareemployed to connect the network interface to the bus. While thecommunication connection is shown for illustrative clarity inside thecomputer system, it can also be external to the computer system 210. Thehardware/software necessary for connection to the network interface mayinclude, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

FIG. 7 illustrates a logic diagram of a control system 470 of a surgicalinstrument or tool in accordance with one or more aspects of the presentdisclosure. The system 470 may comprise a control circuit. The controlcircuit may include a microcontroller 461 comprising a processor 462 anda memory 468. One or more of sensors 472, 474, 476, for example, providereal-time feedback to the processor 462. A motor 482, driven by a motordriver 492, operably couples a longitudinally movable displacementmember to drive the I-beam knife element. A tracking system 480 may beconfigured to determine the position of the longitudinally movabledisplacement member. The position information may be provided to theprocessor 462, which can be programmed or configured to determine theposition of the longitudinally movable drive member as well as theposition of a firing member, firing bar, and I-beam knife element.Additional motors may be provided at the tool driver interface tocontrol I-beam firing, closure tube travel, shaft rotation, andarticulation. A display 473 may display a variety of operatingconditions of the instruments and may include touch screen functionalityfor data input. Information displayed on the display 473 may be overlaidwith images acquired via endoscopic imaging modules.

In one aspect, the microcontroller 461 may be any single-core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one aspect, the main microcontroller 461 may bean LM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising an on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle SRAM, and internal ROM loaded with StellarisWare® software,a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and/orone or more 12-bit ADCs with 12 analog input channels, details of whichare available for the product datasheet.

In one aspect, the microcontroller 461 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The microcontroller 461 may be programmed to perform various functionssuch as precise control over the speed and position of the knife andarticulation systems. In one aspect, the microcontroller 461 may includea processor 462 and a memory 468. The electric motor 482 may be abrushed direct current (DC) motor with a gearbox and mechanical links toan articulation or knife system. In one aspect, a motor driver 492 maybe an A3941 available from Allegro Microsystems, Inc. Other motordrivers may be readily substituted for use in the tracking system 480comprising an absolute positioning system. A detailed description of anabsolute positioning system is described in U.S. Patent ApplicationPublication No. 2017/0296213, titled SYSTEMS AND METHODS FOR CONTROLLINGA SURGICAL STAPLING AND CUTTING INSTRUMENT, which published on Oct. 19,2017, which is herein incorporated by reference in its entirety.

The microcontroller 461 may be programmed to provide precise controlover the speed and position of displacement members and articulationsystems. The microcontroller 461 may be configured to compute a responsein the software of the microcontroller 461. The computed response may becompared to a measured response of the actual system to obtain an“observed” response, which is used for actual feedback decisions. Theobserved response may be a favorable, tuned value that balances thesmooth, continuous nature of the simulated response with the measuredresponse, which can detect outside influences on the system.

In some examples, the motor 482 may be controlled by the motor driver492 and can be employed by the firing system of the surgical instrumentor tool. In various forms, the motor 482 may be a brushed DC drivingmotor having a maximum rotational speed of approximately 25,000 RPM. Insome examples, the motor 482 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 492 may comprise an H-bridge drivercomprising field-effect transistors (FETs), for example. The motor 482can be powered by a power assembly releasably mounted to the handleassembly or tool housing for supplying control power to the surgicalinstrument or tool. The power assembly may comprise a battery which mayinclude a number of battery cells connected in series that can be usedas the power source to power the surgical instrument or tool. In certaincircumstances, the battery cells of the power assembly may bereplaceable and/or rechargeable. In at least one example, the batterycells can be lithium-ion batteries which can be couplable to andseparable from the power assembly.

The motor driver 492 may be an A3941 available from AllegroMicrosystems, Inc. The A3941 492 may be a full-bridge controller for usewith external N-channel power metal-oxide semiconductor field-effecttransistors (MOSFETs) specifically designed for inductive loads, such asbrush DC motors. The driver 492 may comprise a unique charge pumpregulator that can provide full (>10 V) gate drive for battery voltagesdown to 7 V and can allow the A3941 to operate with a reduced gatedrive, down to 5.5 V. A bootstrap capacitor may be employed to providethe above battery supply voltage required for N-channel MOSFETs. Aninternal charge pump for the high-side drive may allow DC (100% dutycycle) operation. The full bridge can be driven in fast or slow decaymodes using diode or synchronous rectification. In the slow decay mode,current recirculation can be through the high-side or the lowside FETs.The power FETs may be protected from shoot-through byresistor-adjustable dead time. Integrated diagnostics provideindications of undervoltage, overtemperature, and power bridge faultsand can be configured to protect the power MOSFETs under most shortcircuit conditions. Other motor drivers may be readily substituted foruse in the tracking system 480 comprising an absolute positioningsystem.

The tracking system 480 may comprise a controlled motor drive circuitarrangement comprising a position sensor 472 according to one aspect ofthis disclosure. The position sensor 472 for an absolute positioningsystem may provide a unique position signal corresponding to thelocation of a displacement member. In some examples, the displacementmember may represent a longitudinally movable drive member comprising arack of drive teeth for meshing engagement with a corresponding drivegear of a gear reducer assembly. In some examples, the displacementmember may represent the firing member, which could be adapted andconfigured to include a rack of drive teeth. In some examples, thedisplacement member may represent a firing bar or the I-beam, each ofwhich can be adapted and configured to include a rack of drive teeth.Accordingly, as used herein, the term displacement member can be usedgenerically to refer to any movable member of the surgical instrument ortool such as the drive member, the firing member, the firing bar, theI-beam, or any element that can be displaced. In one aspect, thelongitudinally movable drive member can be coupled to the firing member,the firing bar, and the I-beam. Accordingly, the absolute positioningsystem can, in effect, track the linear displacement of the I-beam bytracking the linear displacement of the longitudinally movable drivemember. In various aspects, the displacement member may be coupled toany position sensor 472 suitable for measuring linear displacement.Thus, the longitudinally movable drive member, the firing member, thefiring bar, or the I-beam, or combinations thereof, may be coupled toany suitable linear displacement sensor. Linear displacement sensors mayinclude contact or non-contact displacement sensors. Linear displacementsensors may comprise linear variable differential transformers (LVDT),differential variable reluctance transducers (DVRT), a slidepotentiometer, a magnetic sensing system comprising a movable magnet anda series of linearly arranged Hall effect sensors, a magnetic sensingsystem comprising a fixed magnet and a series of movable, linearlyarranged Hall effect sensors, an optical sensing system comprising amovable light source and a series of linearly arranged photo diodes orphoto detectors, an optical sensing system comprising a fixed lightsource and a series of movable linearly, arranged photo diodes or photodetectors, or any combination thereof.

The electric motor 482 can include a rotatable shaft that operablyinterfaces with a gear assembly that is mounted in meshing engagementwith a set, or rack, of drive teeth on the displacement member. A sensorelement may be operably coupled to a gear assembly such that a singlerevolution of the position sensor 472 element corresponds to some linearlongitudinal translation of the displacement member. An arrangement ofgearing and sensors can be connected to the linear actuator, via a rackand pinion arrangement, or a rotary actuator, via a spur gear or otherconnection. A power source may supply power to the absolute positioningsystem and an output indicator may display the output of the absolutepositioning system. The displacement member may represent thelongitudinally movable drive member comprising a rack of drive teethformed thereon for meshing engagement with a corresponding drive gear ofthe gear reducer assembly. The displacement member may represent thelongitudinally movable firing member, firing bar, I-beam, orcombinations thereof.

A single revolution of the sensor element associated with the positionsensor 472 may be equivalent to a longitudinal linear displacement d1 ofthe of the displacement member, where d1 is the longitudinal lineardistance that the displacement member moves from point “a” to point “b”after a single revolution of the sensor element coupled to thedisplacement member. The sensor arrangement may be connected via a gearreduction that results in the position sensor 472 completing one or morerevolutions for the full stroke of the displacement member. The positionsensor 472 may complete multiple revolutions for the full stroke of thedisplacement member.

A series of switches, where n is an integer greater than one, may beemployed alone or in combination with a gear reduction to provide aunique position signal for more than one revolution of the positionsensor 472. The state of the switches may be fed back to themicrocontroller 461 that applies logic to determine a unique positionsignal corresponding to the longitudinal linear displacement d1+d2+ . .. dn of the displacement member. The output of the position sensor 472is provided to the microcontroller 461. The position sensor 472 of thesensor arrangement may comprise a magnetic sensor, an analog rotarysensor like a potentiometer, or an array of analog Hall-effect elements,which output a unique combination of position signals or values.

The position sensor 472 may comprise any number of magnetic sensingelements, such as, for example, magnetic sensors classified according towhether they measure the total magnetic field or the vector componentsof the magnetic field. The techniques used to produce both types ofmagnetic sensors may encompass many aspects of physics and electronics.The technologies used for magnetic field sensing may include searchcoil, fluxgate, optically pumped, nuclear precession, SQUID,Hall-effect, anisotropic magnetoresistance, giant magnetoresistance,magnetic tunnel junctions, giant magnetoimpedance,magnetostrictive/piezoelectric composites, magnetodiode,magnetotransistor, fiber-optic, magneto-optic, andmicroelectromechanical systems-based magnetic sensors, among others.

In one aspect, the position sensor 472 for the tracking system 480comprising an absolute positioning system may comprise a magnetic rotaryabsolute positioning system. The position sensor 472 may be implementedas an AS5055EQFT single-chip magnetic rotary position sensor availablefrom Austria Microsystems, AG. The position sensor 472 is interfacedwith the microcontroller 461 to provide an absolute positioning system.The position sensor 472 may be a low-voltage and low-power component andincludes four Hall-effect elements in an area of the position sensor 472that may be located above a magnet. A high-resolution ADC and a smartpower management controller may also be provided on the chip. Acoordinate rotation digital computer (CORDIC) processor, also known asthe digit-by-digit method and Volder's algorithm, may be provided toimplement a simple and efficient algorithm to calculate hyperbolic andtrigonometric functions that require only addition, subtraction,bitshift, and table lookup operations. The angle position, alarm bits,and magnetic field information may be transmitted over a standard serialcommunication interface, such as a serial peripheral interface (SPI)interface, to the microcontroller 461. The position sensor 472 mayprovide 12 or 14 bits of resolution. The position sensor 472 may be anAS5055 chip provided in a small QFN 16-pin 4×4×0.85 mm package.

The tracking system 480 comprising an absolute positioning system maycomprise and/or be programmed to implement a feedback controller, suchas a PID, state feedback, and adaptive controller. A power sourceconverts the signal from the feedback controller into a physical inputto the system: in this case the voltage. Other examples include a PWM ofthe voltage, current, and force. Other sensor(s) may be provided tomeasure physical parameters of the physical system in addition to theposition measured by the position sensor 472. In some aspects, the othersensor(s) can include sensor arrangements such as those described inU.S. Pat. No. 9,345,481, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM, which issued on May 24, 2016, which is herein incorporated byreference in its entirety; U.S. Patent Application Publication No.2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,which published on Sep. 18, 2014, which is herein incorporated byreference in its entirety; and U.S. patent application Ser. No.15/628,175, titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OFA SURGICAL STAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, whichis herein incorporated by reference in its entirety. In a digital signalprocessing system, an absolute positioning system is coupled to adigital data acquisition system where the output of the absolutepositioning system will have a finite resolution and sampling frequency.The absolute positioning system may comprise a compare-and-combinecircuit to combine a computed response with a measured response usingalgorithms, such as a weighted average and a theoretical control loop,that drive the computed response towards the measured response. Thecomputed response of the physical system may take into accountproperties like mass, inertial, viscous friction, inductance resistance,etc., to predict what the states and outputs of the physical system willbe by knowing the input.

The absolute positioning system may provide an absolute position of thedisplacement member upon power-up of the instrument, without retractingor advancing the displacement member to a reset (zero or home) positionas may be required with conventional rotary encoders that merely countthe number of steps forwards or backwards that the motor 482 has takento infer the position of a device actuator, drive bar, knife, or thelike.

A sensor 474, such as, for example, a strain gauge or a micro-straingauge, may be configured to measure one or more parameters of the endeffector, such as, for example, the amplitude of the strain exerted onthe anvil during a clamping operation, which can be indicative of theclosure forces applied to the anvil. The measured strain may beconverted to a digital signal and provided to the processor 462.Alternatively, or in addition to the sensor 474, a sensor 476, such as,for example, a load sensor, can measure the closure force applied by theclosure drive system to the anvil. The sensor 476, such as, for example,a load sensor, can measure the firing force applied to an I-beam in afiring stroke of the surgical instrument or tool. The I-beam isconfigured to engage a wedge sled, which is configured to upwardly camstaple drivers to force out staples into deforming contact with ananvil. The I-beam also may include a sharpened cutting edge that can beused to sever tissue as the I-beam is advanced distally by the firingbar. Alternatively, a current sensor 478 can be employed to measure thecurrent drawn by the motor 482. The force required to advance the firingmember can correspond to the current drawn by the motor 482, forexample. The measured force may be converted to a digital signal andprovided to the processor 462.

In one form, the strain gauge sensor 474 can be used to measure theforce applied to the tissue by the end effector. A strain gauge can becoupled to the end effector to measure the force on the tissue beingtreated by the end effector. A system for measuring forces applied tothe tissue grasped by the end effector may comprise a strain gaugesensor 474, such as, for example, a micro-strain gauge, that can beconfigured to measure one or more parameters of the end effector, forexample. In one aspect, the strain gauge sensor 474 can measure theamplitude or magnitude of the strain exerted on a jaw member of an endeffector during a clamping operation, which can be indicative of thetissue compression. The measured strain can be converted to a digitalsignal and provided to a processor 462 of the microcontroller 461. Aload sensor 476 can measure the force used to operate the knife element,for example, to cut the tissue captured between the anvil and the staplecartridge. A magnetic field sensor can be employed to measure thethickness of the captured tissue. The measurement of the magnetic fieldsensor also may be converted to a digital signal and provided to theprocessor 462.

The measurements of the tissue compression, the tissue thickness, and/orthe force required to close the end effector on the tissue, asrespectively measured by the sensors 474, 476, can be used by themicrocontroller 461 to characterize the selected position of the firingmember and/or the corresponding value of the speed of the firing member.In one instance, a memory 468 may store a technique, an equation, and/ora lookup table which can be employed by the microcontroller 461 in theassessment.

The control system 470 of the surgical instrument or tool also maycomprise wired or wireless communication circuits to communicate withthe modular communication hub 203 as shown in FIGS. 5 and 6.

FIG. 8 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions. Incertain instances, a first motor can be activated to perform a firstfunction, a second motor can be activated to perform a second function,a third motor can be activated to perform a third function, a fourthmotor can be activated to perform a fourth function, and so on. Incertain instances, the plurality of motors of robotic surgicalinstrument 600 can be individually activated to cause firing, closure,and/or articulation motions in the end effector. The firing, closure,and/or articulation motions can be transmitted to the end effectorthrough a shaft assembly, for example.

In certain instances, the surgical instrument system or tool may includea firing motor 602. The firing motor 602 may be operably coupled to afiring motor drive assembly 604 which can be configured to transmitfiring motions, generated by the motor 602 to the end effector, inparticular to displace the I-beam element. In certain instances, thefiring motions generated by the motor 602 may cause the staples to bedeployed from the staple cartridge into tissue captured by the endeffector and/or the cutting edge of the I-beam element to be advanced tocut the captured tissue, for example. The I-beam element may beretracted by reversing the direction of the motor 602.

In certain instances, the surgical instrument or tool may include aclosure motor 603. The closure motor 603 may be operably coupled to aclosure motor drive assembly 605 which can be configured to transmitclosure motions, generated by the motor 603 to the end effector, inparticular to displace a closure tube to close the anvil and compresstissue between the anvil and the staple cartridge. The closure motionsmay cause the end effector to transition from an open configuration toan approximated configuration to capture tissue, for example. The endeffector may be transitioned to an open position by reversing thedirection of the motor 603.

In certain instances, the surgical instrument or tool may include one ormore articulation motors 606 a, 606 b, for example. The motors 606 a,606 b may be operably coupled to respective articulation motor driveassemblies 608 a, 608 b, which can be configured to transmitarticulation motions generated by the motors 606 a, 606 b to the endeffector. In certain instances, the articulation motions may cause theend effector to articulate relative to the shaft, for example.

As described herein, the surgical instrument or tool may include aplurality of motors which may be configured to perform variousindependent functions. In certain instances, the plurality of motors ofthe surgical instrument or tool can be individually or separatelyactivated to perform one or more functions while the other motors remaininactive. For example, the articulation motors 606 a, 606 b can beactivated to cause the end effector to be articulated while the firingmotor 602 remains inactive. Alternatively, the firing motor 602 can beactivated to fire the plurality of staples, and/or to advance thecutting edge, while the articulation motor 606 remains inactive.Furthermore, the closure motor 603 may be activated simultaneously withthe firing motor 602 to cause the closure tube and the I-beam element toadvance distally as described in more detail hereinbelow.

In certain instances, the surgical instrument or tool may include acommon control module 610 which can be employed with a plurality ofmotors of the surgical instrument or tool. In certain instances, thecommon control module 610 may accommodate one of the plurality of motorsat a time. For example, the common control module 610 can be couplableto and separable from the plurality of motors of the robotic surgicalinstrument individually. In certain instances, a plurality of the motorsof the surgical instrument or tool may share one or more common controlmodules such as the common control module 610. In certain instances, aplurality of motors of the surgical instrument or tool can beindividually and selectively engaged with the common control module 610.In certain instances, the common control module 610 can be selectivelyswitched from interfacing with one of a plurality of motors of thesurgical instrument or tool to interfacing with another one of theplurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 can beselectively switched between operable engagement with the articulationmotors 606 a, 606 b and operable engagement with either the firing motor602 or the closure motor 603. In at least one example, as illustrated inFIG. 8, a switch 614 can be moved or transitioned between a plurality ofpositions and/or states. In a first position 616, the switch 614 mayelectrically couple the common control module 610 to the firing motor602; in a second position 617, the switch 614 may electrically couplethe common control module 610 to the closure motor 603; in a thirdposition 618 a, the switch 614 may electrically couple the commoncontrol module 610 to the first articulation motor 606 a; and in afourth position 618 b, the switch 614 may electrically couple the commoncontrol module 610 to the second articulation motor 606 b, for example.In certain instances, separate common control modules 610 can beelectrically coupled to the firing motor 602, the closure motor 603, andthe articulations motor 606 a, 606 b at the same time. In certaininstances, the switch 614 may be a mechanical switch, anelectromechanical switch, a solid-state switch, or any suitableswitching mechanism.

Each of the motors 602, 603, 606 a, 606 b may comprise a torque sensorto measure the output torque on the shaft of the motor. The force on anend effector may be sensed in any conventional manner, such as by forcesensors on the outer sides of the jaws or by a torque sensor for themotor actuating the jaws.

In various instances, as illustrated in FIG. 8, the common controlmodule 610 may comprise a motor driver 626 which may comprise one ormore H-Bridge FETs. The motor driver 626 may modulate the powertransmitted from a power source 628 to a motor coupled to the commoncontrol module 610 based on input from a microcontroller 620 (the“controller”), for example. In certain instances, the microcontroller620 can be employed to determine the current drawn by the motor, forexample, while the motor is coupled to the common control module 610, asdescribed herein.

In certain instances, the microcontroller 620 may include amicroprocessor 622 (the “processor”) and one or more non-transitorycomputer-readable mediums or memory units 624 (the “memory”). In certaininstances, the memory 624 may store various program instructions, whichwhen executed may cause the processor 622 to perform a plurality offunctions and/or calculations described herein. In certain instances,one or more of the memory units 624 may be coupled to the processor 622,for example.

In certain instances, the power source 628 can be employed to supplypower to the microcontroller 620, for example. In certain instances, thepower source 628 may comprise a battery (or “battery pack” or “powerpack”), such as a lithium-ion battery, for example. In certaininstances, the battery pack may be configured to be releasably mountedto a handle for supplying power to the surgical instrument 600. A numberof battery cells connected in series may be used as the power source628. In certain instances, the power source 628 may be replaceableand/or rechargeable, for example.

In various instances, the processor 622 may control the motor driver 626to control the position, direction of rotation, and/or velocity of amotor that is coupled to the common control module 610. In certaininstances, the processor 622 can signal the motor driver 626 to stopand/or disable a motor that is coupled to the common control module 610.It should be understood that the term “processor” as used hereinincludes any suitable microprocessor, microcontroller, or other basiccomputing device that incorporates the functions of a computer's centralprocessing unit (CPU) on an integrated circuit or, at most, a fewintegrated circuits. The processor can be a multipurpose, programmabledevice that accepts digital data as input, processes it according toinstructions stored in its memory, and provides results as output. Itcan be an example of sequential digital logic, as it may have internalmemory. Processors may operate on numbers and symbols represented in thebinary numeral system.

The processor 622 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. Incertain instances, the microcontroller 620 may be an LM 4F230H5QR,available from Texas Instruments, for example. In at least one example,the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F Processor Corecomprising an on-chip memory of 256 KB single-cycle flash memory, orother non-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle SRAM, an internal ROMloaded with StellarisWare® software, a 2 KB EEPROM, one or more PWMmodules, one or more QEI analogs, one or more 12-bit ADCs with 12 analoginput channels, among other features that are readily available for theproduct datasheet. Other microcontrollers may be readily substituted foruse with the module 4410. Accordingly, the present disclosure should notbe limited in this context.

The memory 624 may include program instructions for controlling each ofthe motors of the surgical instrument 600 that are couplable to thecommon control module 610. For example, the memory 624 may includeprogram instructions for controlling the firing motor 602, the closuremotor 603, and the articulation motors 606 a, 606 b. Such programinstructions may cause the processor 622 to control the firing, closure,and articulation functions in accordance with inputs from algorithms orcontrol programs of the surgical instrument or tool.

One or more mechanisms and/or sensors such as, for example, sensors 630can be employed to alert the processor 622 to the program instructionsthat should be used in a particular setting. For example, the sensors630 may alert the processor 622 to use the program instructionsassociated with firing, closing, and articulating the end effector. Incertain instances, the sensors 630 may comprise position sensors whichcan be employed to sense the position of the switch 614, for example.Accordingly, the processor 622 may use the program instructionsassociated with firing the I-beam of the end effector upon detecting,through the sensors 630 for example, that the switch 614 is in the firstposition 616; the processor 622 may use the program instructionsassociated with closing the anvil upon detecting, through the sensors630 for example, that the switch 614 is in the second position 617; andthe processor 622 may use the program instructions associated witharticulating the end effector upon detecting, through the sensors 630for example, that the switch 614 is in the third or fourth position 618a, 618 b.

FIG. 9 illustrates a diagram of a situationally aware surgical system5100, in accordance with at least one aspect of the present disclosure.In some exemplifications, the data sources 5126 may include, forexample, the modular devices 5102 (which can include sensors configuredto detect parameters associated with the patient and/or the modulardevice itself), databases 5122 (e.g., an EMR database containing patientrecords), and patient monitoring devices 5124 (e.g., a blood pressure(BP) monitor and an electrocardiography (EKG) monitor). The surgical hub5104 can be configured to derive the contextual information pertainingto the surgical procedure from the data based upon, for example, theparticular combination(s) of received data or the particular order inwhich the data is received from the data sources 5126. The contextualinformation inferred from the received data can include, for example,the type of surgical procedure being performed, the particular step ofthe surgical procedure that the surgeon is performing, the type oftissue being operated on, or the body cavity that is the subject of theprocedure. This ability by some aspects of the surgical hub 5104 toderive or infer information related to the surgical procedure fromreceived data can be referred to as “situational awareness.” In anexemplification, the surgical hub 5104 can incorporate a situationalawareness system, which is the hardware and/or programming associatedwith the surgical hub 5104 that derives contextual informationpertaining to the surgical procedure from the received data.

The situational awareness system of the surgical hub 5104 can beconfigured to derive the contextual information from the data receivedfrom the data sources 5126 in a variety of different ways. In anexemplification, the situational awareness system can include a patternrecognition system, or machine learning system (e.g., an artificialneural network), that has been trained on training data to correlatevarious inputs (e.g., data from databases 5122, patient monitoringdevices 5124, and/or modular devices 5102) to corresponding contextualinformation regarding a surgical procedure. In other words, a machinelearning system can be trained to accurately derive contextualinformation regarding a surgical procedure from the provided inputs. Inexamples, the situational awareness system can include a lookup tablestoring pre-characterized contextual information regarding a surgicalprocedure in association with one or more inputs (or ranges of inputs)corresponding to the contextual information. In response to a query withone or more inputs, the lookup table can return the correspondingcontextual information for the situational awareness system forcontrolling the modular devices 5102. In examples, the contextualinformation received by the situational awareness system of the surgicalhub 5104 can be associated with a particular control adjustment or setof control adjustments for one or more modular devices 5102. Inexamples, the situational awareness system can include a further machinelearning system, lookup table, or other such system, which generates orretrieves one or more control adjustments for one or more modulardevices 5102 when provided the contextual information as input.

A surgical hub 5104 incorporating a situational awareness system canprovide a number of benefits for the surgical system 5100. One benefitmay include improving the interpretation of sensed and collected data,which would in turn improve the processing accuracy and/or the usage ofthe data during the course of a surgical procedure. To return to aprevious example, a situationally aware surgical hub 5104 coulddetermine what type of tissue was being operated on; therefore, when anunexpectedly high force to close the surgical instrument's end effectoris detected, the situationally aware surgical hub 5104 could correctlyramp up or ramp down the motor of the surgical instrument for the typeof tissue.

The type of tissue being operated can affect the adjustments that aremade to the compression rate and load thresholds of a surgical staplingand cutting instrument for a particular tissue gap measurement. Asituationally aware surgical hub 5104 could infer whether a surgicalprocedure being performed is a thoracic or an abdominal procedure,allowing the surgical hub 5104 to determine whether the tissue clampedby an end effector of the surgical stapling and cutting instrument islung (for a thoracic procedure) or stomach (for an abdominal procedure)tissue. The surgical hub 5104 could then adjust the compression rate andload thresholds of the surgical stapling and cutting instrumentappropriately for the type of tissue.

The type of body cavity being operated in during an insufflationprocedure can affect the function of a smoke evacuator. A situationallyaware surgical hub 5104 could determine whether the surgical site isunder pressure (by determining that the surgical procedure is utilizinginsufflation) and determine the procedure type. As a procedure type canbe generally performed in a specific body cavity, the surgical hub 5104could then control the motor rate of the smoke evacuator appropriatelyfor the body cavity being operated in. Thus, a situationally awaresurgical hub 5104 could provide a consistent amount of smoke evacuationfor both thoracic and abdominal procedures.

The type of procedure being performed can affect the optimal energylevel for an ultrasonic surgical instrument or radio frequency (RF)electrosurgical instrument to operate at. Arthroscopic procedures, forexample, may require higher energy levels because the end effector ofthe ultrasonic surgical instrument or RF electrosurgical instrument isimmersed in fluid. A situationally aware surgical hub 5104 coulddetermine whether the surgical procedure is an arthroscopic procedure.The surgical hub 5104 could then adjust the RF power level or theultrasonic amplitude of the generator (i.e., “energy level”) tocompensate for the fluid filled environment. Relatedly, the type oftissue being operated on can affect the optimal energy level for anultrasonic surgical instrument or RF electrosurgical instrument tooperate at. A situationally aware surgical hub 5104 could determine whattype of surgical procedure is being performed and then customize theenergy level for the ultrasonic surgical instrument or RFelectrosurgical instrument, respectively, according to the expectedtissue profile for the surgical procedure. Furthermore, a situationallyaware surgical hub 5104 can be configured to adjust the energy level forthe ultrasonic surgical instrument or RF electrosurgical instrumentthroughout the course of a surgical procedure, rather than just on aprocedure-by-procedure basis. A situationally aware surgical hub 5104could determine what step of the surgical procedure is being performedor will subsequently be performed and then update the control algorithmsfor the generator and/or ultrasonic surgical instrument or RFelectrosurgical instrument to set the energy level at a valueappropriate for the expected tissue type according to the surgicalprocedure step.

In examples, data can be drawn from additional data sources 5126 toimprove the conclusions that the surgical hub 5104 draws from one datasource 5126. A situationally aware surgical hub 5104 could augment datathat it receives from the modular devices 5102 with contextualinformation that it has built up regarding the surgical procedure fromother data sources 5126. For example, a situationally aware surgical hub5104 can be configured to determine whether hemostasis has occurred(i.e., whether bleeding at a surgical site has stopped) according tovideo or image data received from a medical imaging device. However, insome cases the video or image data can be inconclusive. Therefore, in anexemplification, the surgical hub 5104 can be further configured tocompare a physiologic measurement (e.g., blood pressure sensed by a BPmonitor communicably connected to the surgical hub 5104) with the visualor image data of hemostasis (e.g., from a medical imaging device 124(FIG. 2) communicably coupled to the surgical hub 5104) to make adetermination on the integrity of the staple line or tissue weld. Inother words, the situational awareness system of the surgical hub 5104can consider the physiological measurement data to provide additionalcontext in analyzing the visualization data. The additional context canbe useful when the visualization data may be inconclusive or incompleteon its own.

For example, a situationally aware surgical hub 5104 could proactivelyactivate the generator to which an RF electrosurgical instrument isconnected if it determines that a subsequent step of the procedurerequires the use of the instrument. Proactively activating the energysource can allow the instrument to be ready for use a soon as thepreceding step of the procedure is completed.

The situationally aware surgical hub 5104 could determine whether thecurrent or subsequent step of the surgical procedure requires adifferent view or degree of magnification on the display according tothe feature(s) at the surgical site that the surgeon is expected to needto view. The surgical hub 5104 could then proactively change thedisplayed view (supplied by, e.g., a medical imaging device for thevisualization system 108) accordingly so that the display automaticallyadjusts throughout the surgical procedure.

The situationally aware surgical hub 5104 could determine which step ofthe surgical procedure is being performed or will subsequently beperformed and whether particular data or comparisons between data willbe required for that step of the surgical procedure. The surgical hub5104 can be configured to automatically call up data screens based uponthe step of the surgical procedure being performed, without waiting forthe surgeon to ask for the particular information.

Errors may be checked during the setup of the surgical procedure orduring the course of the surgical procedure. For example, thesituationally aware surgical hub 5104 could determine whether theoperating theater is setup properly or optimally for the surgicalprocedure to be performed. The surgical hub 5104 can be configured todetermine the type of surgical procedure being performed, retrieve thecorresponding checklists, product location, or setup needs (e.g., from amemory), and then compare the current operating theater layout to thestandard layout for the type of surgical procedure that the surgical hub5104 determines is being performed. In some exemplifications, thesurgical hub 5104 can be configured to compare the list of items for theprocedure and/or a list of devices paired with the surgical hub 5104 toa recommended or anticipated manifest of items and/or devices for thegiven surgical procedure. If there are any discontinuities between thelists, the surgical hub 5104 can be configured to provide an alertindicating that a particular modular device 5102, patient monitoringdevice 5124, and/or other surgical item is missing. In someexemplifications, the surgical hub 5104 can be configured to determinethe relative distance or position of the modular devices 5102 andpatient monitoring devices 5124 via proximity sensors, for example. Thesurgical hub 5104 can compare the relative positions of the devices to arecommended or anticipated layout for the particular surgical procedure.If there are any discontinuities between the layouts, the surgical hub5104 can be configured to provide an alert indicating that the currentlayout for the surgical procedure deviates from the recommended layout.

The situationally aware surgical hub 5104 could determine whether thesurgeon (or other medical personnel) was making an error or otherwisedeviating from the expected course of action during the course of asurgical procedure. For example, the surgical hub 5104 can be configuredto determine the type of surgical procedure being performed, retrievethe corresponding list of steps or order of equipment usage (e.g., froma memory), and then compare the steps being performed or the equipmentbeing used during the course of the surgical procedure to the expectedsteps or equipment for the type of surgical procedure that the surgicalhub 5104 determined is being performed. In some exemplifications, thesurgical hub 5104 can be configured to provide an alert indicating thatan unexpected action is being performed or an unexpected device is beingutilized at the particular step in the surgical procedure.

The surgical instruments (and other modular devices 5102) may beadjusted for the particular context of each surgical procedure (such asadjusting to different tissue types) and validating actions during asurgical procedure. Next steps, data, and display adjustments may beprovided to surgical instruments (and other modular devices 5102) in thesurgical theater according to the specific context of the procedure.

FIG. 10 illustrates a timeline 5200 of an illustrative surgicalprocedure and the contextual information that a surgical hub 5104 canderive from the data received from the data sources 5126 at each step inthe surgical procedure. In the following description of the timeline5200 illustrated in FIG. 9, reference should also be made to FIG. 9. Thetimeline 5200 may depict the typical steps that would be taken by thenurses, surgeons, and other medical personnel during the course of alung segmentectomy procedure, beginning with setting up the operatingtheater and ending with transferring the patient to a post-operativerecovery room. The situationally aware surgical hub 5104 may receivedata from the data sources 5126 throughout the course of the surgicalprocedure, including data generated each time medical personnel utilizea modular device 5102 that is paired with the surgical hub 5104. Thesurgical hub 5104 can receive this data from the paired modular devices5102 and other data sources 5126 and continually derive inferences(i.e., contextual information) about the ongoing procedure as new datais received, such as which step of the procedure is being performed atany given time. The situational awareness system of the surgical hub5104 can be able to, for example, record data pertaining to theprocedure for generating reports, verify the steps being taken by themedical personnel, provide data or prompts (e.g., via a display screen)that may be pertinent for the particular procedural step, adjust modulardevices 5102 based on the context (e.g., activate monitors, adjust theFOV of the medical imaging device, or change the energy level of anultrasonic surgical instrument or RF electrosurgical instrument), andtake any other such action described herein.

As the first step 5202 in this illustrative procedure, the hospitalstaff members may retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 5104determines that the procedure to be performed is a thoracic procedure.Second 5204, the staff members may scan the incoming medical suppliesfor the procedure. The surgical hub 5104 cross-references the scannedsupplies with a list of supplies that can be utilized in various typesof procedures and confirms that the mix of supplies corresponds to athoracic procedure. Further, the surgical hub 5104 may also be able todetermine that the procedure is not a wedge procedure (because theincoming supplies either lack certain supplies that are necessary for athoracic wedge procedure or do not otherwise correspond to a thoracicwedge procedure). Third 5206, the medical personnel may scan the patientband via a scanner 5128 that is communicably connected to the surgicalhub 5104. The surgical hub 5104 can then confirm the patient's identitybased on the scanned data. Fourth 5208, the medical staff turns on theauxiliary equipment. The auxiliary equipment being utilized can varyaccording to the type of surgical procedure and the techniques to beused by the surgeon, but in this illustrative case they include a smokeevacuator, insufflator, and medical imaging device. When activated, theauxiliary equipment that are modular devices 5102 can automatically pairwith the surgical hub 5104 that may be located within a particularvicinity of the modular devices 5102 as part of their initializationprocess. The surgical hub 5104 can then derive contextual informationabout the surgical procedure by detecting the types of modular devices5102 that pair with it during this pre-operative or initializationphase. In this particular example, the surgical hub 5104 may determinethat the surgical procedure is a VATS procedure based on this particularcombination of paired modular devices 5102. Based on the combination ofthe data from the patient's EMR, the list of medical supplies to be usedin the procedure, and the type of modular devices 5102 that connect tothe hub, the surgical hub 5104 can generally infer the specificprocedure that the surgical team will be performing. Once the surgicalhub 5104 knows what specific procedure is being performed, the surgicalhub 5104 can then retrieve the steps of that procedure from a memory orfrom the cloud and then cross-reference the data it subsequentlyreceives from the connected data sources 5126 (e.g., modular devices5102 and patient monitoring devices 5124) to infer what step of thesurgical procedure the surgical team is performing. Fifth 5210, thestaff members attach the EKG electrodes and other patient monitoringdevices 5124 to the patient. The EKG electrodes and other patientmonitoring devices 5124 may pair with the surgical hub 5104. As thesurgical hub 5104 begins receiving data from the patient monitoringdevices 5124, the surgical hub 5104 may confirm that the patient is inthe operating theater, as described in the process 5207, for example.Sixth 5212, the medical personnel may induce anesthesia in the patient.The surgical hub 5104 can infer that the patient is under anesthesiabased on data from the modular devices 5102 and/or patient monitoringdevices 5124, including EKG data, blood pressure data, ventilator data,or combinations thereof. for example. Upon completion of the sixth step5212, the pre-operative portion of the lung segmentectomy procedure iscompleted and the operative portion begins.

Seventh 5214, the patient's lung that is being operated on may becollapsed (while ventilation is switched to the contralateral lung). Thesurgical hub 5104 can infer from the ventilator data that the patient'slung has been collapsed, for example. The surgical hub 5104 can inferthat the operative portion of the procedure has commenced as it cancompare the detection of the patient's lung collapsing to the expectedsteps of the procedure (which can be accessed or retrieved previously)and thereby determine that collapsing the lung can be the firstoperative step in this particular procedure. Eighth 5216, the medicalimaging device 5108 (e.g., a scope) may be inserted and video from themedical imaging device may be initiated. The surgical hub 5104 mayreceive the medical imaging device data (i.e., video or image data)through its connection to the medical imaging device. Upon receipt ofthe medical imaging device data, the surgical hub 5104 can determinethat the laparoscopic portion of the surgical procedure has commenced.Further, the surgical hub 5104 can determine that the particularprocedure being performed is a segmentectomy, as opposed to a lobectomy(note that a wedge procedure has already been discounted by the surgicalhub 5104 based on data received at the second step 5204 of theprocedure). The data from the medical imaging device 124 (FIG. 2) can beutilized to determine contextual information regarding the type ofprocedure being performed in a number of different ways, including bydetermining the angle at which the medical imaging device is orientedwith respect to the visualization of the patient's anatomy, monitoringthe number or medical imaging devices being utilized (i.e., that areactivated and paired with the surgical hub 5104), and monitoring thetypes of visualization devices utilized. For example, one technique forperforming a VATS lobectomy may place the camera in the lower anteriorcorner of the patient's chest cavity above the diaphragm, whereas onetechnique for performing a VATS segmentectomy places the camera in ananterior intercostal position relative to the segmental fissure. Usingpattern recognition or machine learning techniques, for example, thesituational awareness system can be trained to recognize the positioningof the medical imaging device according to the visualization of thepatient's anatomy. An example technique for performing a VATS lobectomymay utilize a single medical imaging device. An example technique forperforming a VATS segmentectomy utilizes multiple cameras. An exampletechnique for performing a VATS segmentectomy utilizes an infrared lightsource (which can be communicably coupled to the surgical hub as part ofthe visualization system) to visualize the segmental fissure, which isnot utilized in a VATS lobectomy. By tracking any or all of this datafrom the medical imaging device 5108, the surgical hub 5104 can therebydetermine the specific type of surgical procedure being performed and/orthe technique being used for a particular type of surgical procedure.

Ninth 5218, the surgical team may begin the dissection step of theprocedure. The surgical hub 5104 can infer that the surgeon is in theprocess of dissecting to mobilize the patient's lung because it receivesdata from the RF or ultrasonic generator indicating that an energyinstrument is being fired. The surgical hub 5104 can cross-reference thereceived data with the retrieved steps of the surgical procedure todetermine that an energy instrument being fired at this point in theprocess (i.e., after the completion of the previously discussed steps ofthe procedure) corresponds to the dissection step. Tenth 5220, thesurgical team may proceed to the ligation step of the procedure. Thesurgical hub 5104 can infer that the surgeon is ligating arteries andveins because it may receive data from the surgical stapling and cuttinginstrument indicating that the instrument is being fired. Similar to theprior step, the surgical hub 5104 can derive this inference bycross-referencing the receipt of data from the surgical stapling andcutting instrument with the retrieved steps in the process. Eleventh5222, the segmentectomy portion of the procedure can be performed. Thesurgical hub 5104 can infer that the surgeon is transecting theparenchyma based on data from the surgical stapling and cuttinginstrument, including data from its cartridge. The cartridge data cancorrespond to the size or type of staple being fired by the instrument,for example. As different types of staples are utilized for differenttypes of tissues, the cartridge data can thus indicate the type oftissue being stapled and/or transected. In this case, the type of staplebeing fired is utilized for parenchyma (or other similar tissue types),which allows the surgical hub 5104 to infer that the segmentectomyportion of the procedure is being performed. Twelfth 5224, the nodedissection step is then performed. The surgical hub 5104 can infer thatthe surgical team is dissecting the node and performing a leak testbased on data received from the generator indicating that an RF orultrasonic instrument is being fired. For this particular procedure, anRF or ultrasonic instrument being utilized after parenchyma wastransected corresponds to the node dissection step, which allows thesurgical hub 5104 to make this inference. It should be noted thatsurgeons regularly switch back and forth between surgicalstapling/cutting instruments and surgical energy (e.g., RF orultrasonic) instruments depending upon the particular step in theprocedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/cutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing. Uponcompletion of the twelfth step 5224, the incisions and closed up and thepost-operative portion of the procedure may begin.

Thirteenth 5226, the patient's anesthesia can be reversed. The surgicalhub 5104 can infer that the patient is emerging from the anesthesiabased on the ventilator data (i.e., the patient's breathing rate beginsincreasing), for example. Lastly, the fourteenth step 5228 may be thatthe medical personnel remove the various patient monitoring devices 5124from the patient. The surgical hub 5104 can thus infer that the patientis being transferred to a recovery room when the hub loses EKG, BP, andother data from the patient monitoring devices 5124. As can be seen fromthe description of this illustrative procedure, the surgical hub 5104can determine or infer when each step of a given surgical procedure istaking place according to data received from the various data sources5126 that are communicably coupled to the surgical hub 5104.

In addition to utilizing the patient data from EMR database(s) to inferthe type of surgical procedure that is to be performed, as illustratedin the first step 5202 of the timeline 5200 depicted in FIG. 10, thepatient data can also be utilized by a situationally aware surgical hub5104 to generate control adjustments for the paired modular devices5102.

FIG. 11 is a block diagram of the computer-implemented interactivesurgical system, in accordance with at least one aspect of the presentdisclosure. In one aspect, the computer-implemented interactive surgicalsystem may be configured to monitor and analyze data related to theoperation of various surgical systems that include surgical hubs,surgical instruments, robotic devices and operating theaters orhealthcare facilities. The computer-implemented interactive surgicalsystem may comprise a cloud-based analytics system. Although thecloud-based analytics system may be described as a surgical system, itmay not be necessarily limited as such and could be a cloud-basedmedical system generally. As illustrated in FIG. 11, the cloud-basedanalytics system may comprise a plurality of surgical instruments 7012(may be the same or similar to instruments 112), a plurality of surgicalhubs 7006 (may be the same or similar to hubs 106), and a surgical datanetwork 7001 (may be the same or similar to network 201) to couple thesurgical hubs 7006 to the cloud 7004 (may be the same or similar tocloud 204). Each of the plurality of surgical hubs 7006 may becommunicatively coupled to one or more surgical instruments 7012. Thehubs 7006 may also be communicatively coupled to the cloud 7004 of thecomputer-implemented interactive surgical system via the network 7001.The cloud 7004 may be a remote centralized source of hardware andsoftware for storing, manipulating, and communicating data generatedbased on the operation of various surgical systems. As shown in FIG. 11,access to the cloud 7004 may be achieved via the network 7001, which maybe the Internet or some other suitable computer network. Surgical hubs7006 that may be coupled to the cloud 7004 can be considered the clientside of the cloud computing system (i.e., cloud-based analytics system).Surgical instruments 7012 may be paired with the surgical hubs 7006 forcontrol and implementation of various surgical procedures or operationsas described herein.

In addition, surgical instruments 7012 may comprise transceivers fordata transmission to and from their corresponding surgical hubs 7006(which may also comprise transceivers). Combinations of surgicalinstruments 7012 and corresponding hubs 7006 may indicate particularlocations, such as operating theaters in healthcare facilities (e.g.,hospitals), for providing medical operations. For example, the memory ofa surgical hub 7006 may store location data. As shown in FIG. 11, thecloud 7004 comprises central servers 7013 (may be same or similar toremote server 7013), hub application servers 7002, data analyticsmodules 7034, and an input/output (“I/O”) interface 7006. The centralservers 7013 of the cloud 7004 collectively administer the cloudcomputing system, which includes monitoring requests by client surgicalhubs 7006 and managing the processing capacity of the cloud 7004 forexecuting the requests. Each of the central servers 7013 may compriseone or more processors 7008 coupled to suitable memory devices 7010which can include volatile memory such as random-access memory (RAM) andnon-volatile memory such as magnetic storage devices. The memory devices7010 may comprise machine executable instructions that when executedcause the processors 7008 to execute the data analytics modules 7034 forthe cloud-based data analysis, operations, recommendations and otheroperations described below. Moreover, the processors 7008 can executethe data analytics modules 7034 independently or in conjunction with hubapplications independently executed by the hubs 7006. The centralservers 7013 also may comprise aggregated medical data databases 2212,which can reside in the memory 2210.

Based on connections to various surgical hubs 7006 via the network 7001,the cloud 7004 can aggregate data from specific data generated byvarious surgical instruments 7012 and their corresponding hubs 7006.Such aggregated data may be stored within the aggregated medicaldatabases 7012 of the cloud 7004. In particular, the cloud 7004 mayadvantageously perform data analysis and operations on the aggregateddata to yield insights and/or perform functions that individual hubs7006 could not achieve on their own. To this end, as shown in FIG. 11,the cloud 7004 and the surgical hubs 7006 are communicatively coupled totransmit and receive information. The I/O interface 7006 is connected tothe plurality of surgical hubs 7006 via the network 7001. In this way,the I/O interface 7006 can be configured to transfer information betweenthe surgical hubs 7006 and the aggregated medical data databases 7011.Accordingly, the I/O interface 7006 may facilitate read/write operationsof the cloud-based analytics system. Such read/write operations may beexecuted in response to requests from hubs 7006. These requests could betransmitted to the hubs 7006 through the hub applications. The I/Ointerface 7006 may include one or more high speed data ports, which mayinclude universal serial bus (USB) ports, IEEE 1394 ports, as well asWi-Fi and Bluetooth I/O interfaces for connecting the cloud 7004 to hubs7006. The hub application servers 7002 of the cloud 7004 may beconfigured to host and supply shared capabilities to softwareapplications (e.g., hub applications) executed by surgical hubs 7006.For example, the hub application servers 7002 may manage requests madeby the hub applications through the hubs 7006, control access to theaggregated medical data databases 7011, and perform load balancing. Thedata analytics modules 7034 are described in further detail withreference to FIG. 12.

The particular cloud computing system configuration described in thepresent disclosure may be specifically designed to address variousissues arising in the context of medical operations and proceduresperformed using medical devices, such as the surgical instruments 7012,112. In particular, the surgical instruments 7012 may be digitalsurgical devices configured to interact with the cloud 7004 forimplementing techniques to improve the performance of surgicaloperations. Various surgical instruments 7012 and/or surgical hubs 7006may comprise touch-controlled user interfaces such that clinicians maycontrol aspects of interaction between the surgical instruments 7012 andthe cloud 7004. Other suitable user interfaces for control such asauditory controlled user interfaces can also be used.

FIG. 12 is a block diagram which illustrates the functional architectureof the computer-implemented interactive surgical system, in accordancewith at least one aspect of the present disclosure. The cloud-basedanalytics system may include a plurality of data analytics modules 7034that may be executed by the processors 7008 of the cloud 7004 forproviding data analytic solutions to problems specifically arising inthe medical field. As shown in FIG. 12, the functions of the cloud-baseddata analytics modules 7034 may be assisted via hub applications 7014hosted by the hub application servers 7002 that may be accessed onsurgical hubs 7006. The cloud processors 7008 and hub applications 7014may operate in conjunction to execute the data analytics modules 7034.Application program interfaces (APIs) 7016 may define the set ofprotocols and routines corresponding to the hub applications 7014.Additionally, the APIs 7016 may manage the storing and retrieval of datainto and from the aggregated medical databases 7012 for the operationsof the applications 7014. The caches 7018 may also store data (e.g.,temporarily) and may be coupled to the APIs 7016 for more efficientretrieval of data used by the applications 7014. The data analyticsmodules 7034 in FIG. 12 may include modules for resource optimization7020, data collection and aggregation 7022, authorization and security7024, control program updating 7026, patient outcome analysis 7028,recommendations 7030, and data sorting and prioritization 7032. Othersuitable data analytics modules could also be implemented by the cloud7004, according to some aspects. In one aspect, the data analyticsmodules may be used for specific recommendations based on analyzingtrends, outcomes, and other data.

For example, the data collection and aggregation module 7022 could beused to generate self-describing data (e.g., metadata) includingidentification of notable features or configuration (e.g., trends),management of redundant data sets, and storage of the data in paireddata sets which can be grouped by surgery but not necessarily keyed toactual surgical dates and surgeons. In particular, pair data setsgenerated from operations of surgical instruments 7012 can compriseapplying a binary classification, e.g., a bleeding or a non-bleedingevent. More generally, the binary classification may be characterized aseither a desirable event (e.g., a successful surgical procedure) or anundesirable event (e.g., a misfired or misused surgical instrument7012). The aggregated self-describing data may correspond to individualdata received from various groups or subgroups of surgical hubs 7006.Accordingly, the data collection and aggregation module 7022 cangenerate aggregated metadata or other organized data based on raw datareceived from the surgical hubs 7006. To this end, the processors 7008can be operationally coupled to the hub applications 7014 and aggregatedmedical data databases 7011 for executing the data analytics modules7034. The data collection and aggregation module 7022 may store theaggregated organized data into the aggregated medical data databases2212.

The resource optimization module 7020 can be configured to analyze thisaggregated data to determine an optimal usage of resources for aparticular or group of healthcare facilities. For example, the resourceoptimization module 7020 may determine an optimal order point ofsurgical stapling instruments 7012 for a group of healthcare facilitiesbased on corresponding predicted demand of such instruments 7012. Theresource optimization module 7020 might also assess the resource usageor other operational configurations of various healthcare facilities todetermine whether resource usage could be improved. Similarly, therecommendations module 7030 can be configured to analyze aggregatedorganized data from the data collection and aggregation module 7022 toprovide recommendations. For example, the recommendations module 7030could recommend to healthcare facilities (e.g., medical serviceproviders such as hospitals) that a particular surgical instrument 7012should be upgraded to an improved version based on a higher thanexpected error rate, for example. Additionally, the recommendationsmodule 7030 and/or resource optimization module 7020 could recommendbetter supply chain parameters such as product reorder points andprovide suggestions of different surgical instrument 7012, uses thereof,or procedure steps to improve surgical outcomes. The healthcarefacilities can receive such recommendations via corresponding surgicalhubs 7006. More specific recommendations regarding parameters orconfigurations of various surgical instruments 7012 can also beprovided. Hubs 7006 and/or surgical instruments 7012 each could alsohave display screens that display data or recommendations provided bythe cloud 7004.

The patient outcome analysis module 7028 can analyze surgical outcomesassociated with currently used operational parameters of surgicalinstruments 7012. The patient outcome analysis module 7028 may alsoanalyze and assess other potential operational parameters. In thisconnection, the recommendations module 7030 could recommend using theseother potential operational parameters based on yielding better surgicaloutcomes, such as better sealing or less bleeding. For example, therecommendations module 7030 could transmit recommendations to a surgical7006 regarding when to use a particular cartridge for a correspondingstapling surgical instrument 7012. Thus, the cloud-based analyticssystem, while controlling for common variables, may be configured toanalyze the large collection of raw data and to provide centralizedrecommendations over multiple healthcare facilities (advantageouslydetermined based on aggregated data). For example, the cloud-basedanalytics system could analyze, evaluate, and/or aggregate data based ontype of medical practice, type of patient, number of patients,geographic similarity between medical providers, which medicalproviders/facilities use similar types of instruments, etc., in a waythat no single healthcare facility alone would be able to analyzeindependently. The control program updating module 7026 could beconfigured to implement various surgical instrument 7012 recommendationswhen corresponding control programs are updated. For example, thepatient outcome analysis module 7028 could identify correlations linkingspecific control parameters with successful (or unsuccessful) results.Such correlations may be addressed when updated control programs aretransmitted to surgical instruments 7012 via the control programupdating module 7026. Updates to instruments 7012 that may betransmitted via a corresponding hub 7006 may incorporate aggregatedperformance data that was gathered and analyzed by the data collectionand aggregation module 7022 of the cloud 7004. Additionally, the patientoutcome analysis module 7028 and recommendations module 7030 couldidentify improved methods of using instruments 7012 based on aggregatedperformance data.

The cloud-based analytics system may include security featuresimplemented by the cloud 7004. These security features may be managed bythe authorization and security module 7024. Each surgical hub 7006 canhave associated unique credentials such as username, password, and othersuitable security credentials. These credentials could be stored in thememory 7010 and be associated with a permitted cloud access level. Forexample, based on providing accurate credentials, a surgical hub 7006may be granted access to communicate with the cloud to a predeterminedextent (e.g., may only engage in transmitting or receiving certaindefined types of information). To this end, the aggregated medical datadatabases 7011 of the cloud 7004 may comprise a database of authorizedcredentials for verifying the accuracy of provided credentials.Different credentials may be associated with varying levels ofpermission for interaction with the cloud 7004, such as a predeterminedaccess level for receiving the data analytics generated by the cloud7004. Furthermore, for security purposes, the cloud could maintain adatabase of hubs 7006, instruments 7012, and other devices that maycomprise a “black list” of prohibited devices. In particular, a surgicalhubs 7006 listed on the black list may not be permitted to interact withthe cloud, while surgical instruments 7012 listed on the black list maynot have functional access to a corresponding hub 7006 and/or may beprevented from fully functioning when paired to its corresponding hub7006. Additionally, or alternatively, the cloud 7004 may flaginstruments 7012 based on incompatibility or other specified criteria.In this manner, counterfeit medical devices and improper reuse of suchdevices throughout the cloud-based analytics system can be identifiedand addressed.

The surgical instruments 7012 may use wireless transceivers to transmitwireless signals that may represent, for example, authorizationcredentials for access to corresponding hubs 7006 and the cloud 7004.Wired transceivers may also be used to transmit signals. Suchauthorization credentials can be stored in the respective memory devicesof the surgical instruments 7012. The authorization and security module7024 can determine whether the authorization credentials are accurate orcounterfeit. The authorization and security module 7024 may alsodynamically generate authorization credentials for enhanced security.The credentials could also be encrypted, such as by using hash-basedencryption. Upon transmitting proper authorization, the surgicalinstruments 7012 may transmit a signal to the corresponding hubs 7006and ultimately the cloud 7004 to indicate that the instruments 7012 areready to obtain and transmit medical data. In response, the cloud 7004may transition into a state enabled for receiving medical data forstorage into the aggregated medical data databases 7011. This datatransmission readiness could be indicated by a light indicator on theinstruments 7012, for example. The cloud 7004 can also transmit signalsto surgical instruments 7012 for updating their associated controlprograms. The cloud 7004 can transmit signals that are directed to aparticular class of surgical instruments 7012 (e.g., electrosurgicalinstruments) so that software updates to control programs are onlytransmitted to the appropriate surgical instruments 7012. Moreover, thecloud 7004 could be used to implement system wide solutions to addresslocal or global problems based on selective data transmission andauthorization credentials. For example, if a group of surgicalinstruments 7012 are identified as having a common manufacturing defect,the cloud 7004 may change the authorization credentials corresponding tothis group to implement an operational lockout of the group.

The cloud-based analytics system may allow for monitoring multiplehealthcare facilities (e.g., medical facilities like hospitals) todetermine improved practices and recommend changes (via therecommendations module 2030, for example) accordingly. Thus, theprocessors 7008 of the cloud 7004 can analyze data associated with anindividual healthcare facility to identify the facility and aggregatethe data with other data associated with other healthcare facilities ina group. Groups could be defined based on similar operating practices orgeographical location, for example. In this way, the cloud 7004 mayprovide healthcare facility group wide analysis and recommendations. Thecloud-based analytics system could also be used for enhanced situationalawareness. For example, the processors 7008 may predictively model theeffects of recommendations on the cost and effectiveness for aparticular facility (relative to overall operations and/or variousmedical procedures). The cost and effectiveness associated with thatparticular facility can also be compared to a corresponding local regionof other facilities or any other comparable facilities.

The data sorting and prioritization module 7032 may prioritize and sortdata based on criticality (e.g., the severity of a medical eventassociated with the data, unexpectedness, suspiciousness). This sortingand prioritization may be used in conjunction with the functions of theother data analytics modules 7034 described herein to improve thecloud-based analytics and operations described herein. For example, thedata sorting and prioritization module 7032 can assign a priority to thedata analysis performed by the data collection and aggregation module7022 and patient outcome analysis modules 7028. Different prioritizationlevels can result in particular responses from the cloud 7004(corresponding to a level of urgency) such as escalation for anexpedited response, special processing, exclusion from the aggregatedmedical data databases 7011, or other suitable responses. Moreover, ifnecessary, the cloud 7004 can transmit a request (e.g., a push message)through the hub application servers for additional data fromcorresponding surgical instruments 7012. The push message can result ina notification displayed on the corresponding hubs 7006 for requestingsupporting or additional data. This push message may be required insituations in which the cloud detects a significant irregularity oroutlier and the cloud cannot determine the cause of the irregularity.The central servers 7013 may be programmed to trigger this push messagein certain significant circumstances, such as when data is determined tobe different from an expected value beyond a predetermined threshold orwhen it appears security has been comprised, for example.

Additional example details for the various functions described areprovided in the ensuing descriptions below. Each of the variousdescriptions may utilize the cloud architecture as described in FIGS. 11and 12 as one example of hardware and software implementation.

FIG. 13 illustrates a block diagram of a computer-implemented adaptivesurgical system 9060 that is configured to adaptively generate controlprogram updates for modular devices 9050, in accordance with at leastone aspect of the present disclosure. In some exemplifications, thesurgical system may include a surgical hub 9000, multiple modulardevices 9050 communicably coupled to the surgical hub 9000, and ananalytics system 9100 communicably coupled to the surgical hub 9000.Although a single surgical hub 9000 may be depicted, it should be notedthat the surgical system 9060 can include any number of surgical hubs9000, which can be connected to form a network of surgical hubs 9000that are communicably coupled to the analytics system 9010. In someexemplifications, the surgical hub 9000 may include a processor 9010coupled to a memory 9020 for executing instructions stored thereon and adata relay interface 9030 through which data is transmitted to theanalytics system 9100. In some exemplifications, the surgical hub 9000further may include a user interface 9090 having an input device 9092(e.g., a capacitive touchscreen or a keyboard) for receiving inputs froma user and an output device 9094 (e.g., a display screen) for providingoutputs to a user. Outputs can include data from a query input by theuser, suggestions for products or mixes of products to use in a givenprocedure, and/or instructions for actions to be carried out before,during, or after surgical procedures. The surgical hub 9000 further mayinclude an interface 9040 for communicably coupling the modular devices9050 to the surgical hub 9000. In one aspect, the interface 9040 mayinclude a transceiver that is communicably connectable to the modulardevice 9050 via a wireless communication protocol. The modular devices9050 can include, for example, surgical stapling and cuttinginstruments, electrosurgical instruments, ultrasonic instruments,insufflators, respirators, and display screens. In someexemplifications, the surgical hub 9000 can further be communicablycoupled to one or more patient monitoring devices 9052, such as EKGmonitors or BP monitors. In some exemplifications, the surgical hub 9000can further be communicably coupled to one or more databases 9054 orexternal computer systems, such as an EMR database of the medicalfacility at which the surgical hub 9000 is located.

When the modular devices 9050 are connected to the surgical hub 9000,the surgical hub 9000 can sense or receive perioperative data from themodular devices 9050 and then associate the received perioperative datawith surgical procedural outcome data. The perioperative data mayindicate how the modular devices 9050 were controlled during the courseof a surgical procedure. The procedural outcome data includes dataassociated with a result from the surgical procedure (or a stepthereof), which can include whether the surgical procedure (or a stepthereof) had a positive or negative outcome. For example, the outcomedata could include whether a patient suffered from postoperativecomplications from a particular procedure or whether there was leakage(e.g., bleeding or air leakage) at a particular staple or incision line.The surgical hub 9000 can obtain the surgical procedural outcome data byreceiving the data from an external source (e.g., from an EMR database9054), by directly detecting the outcome (e.g., via one of the connectedmodular devices 9050), or inferring the occurrence of the outcomesthrough a situational awareness system. For example, data regardingpostoperative complications could be retrieved from an EMR database 9054and data regarding staple or incision line leakages could be directlydetected or inferred by a situational awareness system. The surgicalprocedural outcome data can be inferred by a situational awarenesssystem from data received from a variety of data sources, including themodular devices 9050 themselves, the patient monitoring device 9052, andthe databases 9054 to which the surgical hub 9000 is connected.

The surgical hub 9000 can transmit the associated modular device 9050data and outcome data to the analytics system 9100 for processingthereon. By transmitting both the perioperative data indicating how themodular devices 9050 are controlled and the procedural outcome data, theanalytics system 9100 can correlate the different manners of controllingthe modular devices 9050 with surgical outcomes for the particularprocedure type. In some exemplifications, the analytics system 9100 mayinclude a network of analytics servers 9070 that are configured toreceive data from the surgical hubs 9000. Each of the analytics servers9070 can include a memory and a processor coupled to the memory that isexecuting instructions stored thereon to analyze the received data. Insome exemplifications, the analytics servers 9070 may be connected in adistributed computing architecture and/or utilize a cloud computingarchitecture. Based on this paired data, the analytics system 9100 canthen learn optimal or preferred operating parameters for the varioustypes of modular devices 9050, generate adjustments to the controlprograms of the modular devices 9050 in the field, and then transmit (or“push”) updates to the modular devices' 9050 control programs.

Additional detail regarding the computer-implemented interactivesurgical system 9060, including the surgical hub 9000 and variousmodular devices 9050 connectable thereto, are described in connectionwith FIGS. 5-6.

FIG. 14 provides a surgical system 6500 in accordance with the presentdisclosure and may include a surgical instrument 6502 that can be incommunication with a console 6522 or a portable device 6526 through alocal area network 6518 or a cloud network 6520 via a wired or wirelessconnection. In various aspects, the console 6522 and the portable device6526 may be any suitable computing device. The surgical instrument 6502may include a handle 6504, an adapter 6508, and a loading unit 6514. Theadapter 6508 releasably couples to the handle 6504 and the loading unit6514 releasably couples to the adapter 6508 such that the adapter 6508transmits a force from a drive shaft to the loading unit 6514. Theadapter 6508 or the loading unit 6514 may include a force gauge (notexplicitly shown) disposed therein to measure a force exerted on theloading unit 6514. The loading unit 6514 may include an end effector6530 having a first jaw 6532 and a second jaw 6534. The loading unit6514 may be an in-situ loaded or multi-firing loading unit (MFLU) thatallows a clinician to fire a plurality of fasteners multiple timeswithout requiring the loading unit 6514 to be removed from a surgicalsite to reload the loading unit 6514.

The first and second jaws 6532, 6534 may be configured to clamp tissuetherebetween, fire fasteners through the clamped tissue, and sever theclamped tissue. The first jaw 6532 may be configured to fire at leastone fastener a plurality of times, or may be configured to include areplaceable multi-fire fastener cartridge including a plurality offasteners (e.g., staples, clips, etc.) that may be fired more than onetime prior to being replaced. The second jaw 6534 may include an anvilthat deforms or otherwise secures the fasteners about tissue as thefasteners are ejected from the multi-fire fastener cartridge.

The handle 6504 may include a motor that is coupled to the drive shaftto affect rotation of the drive shaft. The handle 6504 may include acontrol interface to selectively activate the motor. The controlinterface may include buttons, switches, levers, sliders, touchscreen,and any other suitable input mechanisms or user interfaces, which can beengaged by a clinician to activate the motor.

The control interface of the handle 6504 may be in communication with acontroller 6528 of the handle 6504 to selectively activate the motor toaffect rotation of the drive shafts. The controller 6528 may be disposedwithin the handle 6504 and is configured to receive input from thecontrol interface and adapter data from the adapter 6508 or loading unitdata from the loading unit 6514. The controller 6528 may analyze theinput from the control interface and the data received from the adapter6508 and/or loading unit 6514 to selectively activate the motor. Thehandle 6504 may also include a display that is viewable by a clinicianduring use of the handle 6504. The display may be configured to displayportions of the adapter or loading unit data before, during, or afterfiring of the instrument 6502.

The adapter 6508 may include an adapter identification device 6510disposed therein and the loading unit 6514 includes a loading unitidentification device 6516 disposed therein. The adapter identificationdevice 6510 may be in communication with the controller 6528, and theloading unit identification device 6516 may be in communication with thecontroller 6528. It will be appreciated that the loading unitidentification device 6516 may be in communication with the adapteridentification device 6510, which relays or passes communication fromthe loading unit identification device 6516 to the controller 6528.

The adapter 6508 may also include a plurality of sensors 6512 (oneshown) disposed thereabout to detect various conditions of the adapter6508 or of the environment (e.g., if the adapter 6508 is connected to aloading unit, if the adapter 6508 is connected to a handle, if the driveshafts are rotating, the torque of the drive shafts, the strain of thedrive shafts, the temperature within the adapter 6508, a number offirings of the adapter 6508, a peak force of the adapter 6508 duringfiring, a total amount of force applied to the adapter 6508, a peakretraction force of the adapter 6508, a number of pauses of the adapter6508 during firing, etc.). The plurality of sensors 6512 may provide aninput to the adapter identification device 6510 in the form of datasignals. The data signals of the plurality of sensors 6512 may be storedwithin, or be used to update the adapter data stored within, the adapteridentification device 6510. The data signals of the plurality of sensors6512 may be analog or digital. The plurality of sensors 6512 may includea force gauge to measure a force exerted on the loading unit 6514 duringfiring.

The handle 6504 and the adapter 6508 can be configured to interconnectthe adapter identification device 6510 and the loading unitidentification device 6516 with the controller 6528 via an electricalinterface. The electrical interface may be a direct electrical interface(i.e., include electrical contacts that engage one another to transmitenergy and signals therebetween). Additionally or alternatively, theelectrical interface may be a non-contact electrical interface towirelessly transmit energy and signals therebetween (e.g., inductivelytransfer). It is also contemplated that the adapter identificationdevice 6510 and the controller 6528 may be in wireless communicationwith one another via a wireless connection separate from the electricalinterface.

The handle 6504 may include a transmitter 6506 that is configured totransmit instrument data from the controller 6528 to other components ofthe system 6500 (e.g., the LAN 6518, the cloud 6520, the console 6522,or the portable device 6526). The transmitter 6506 also may receive data(e.g., cartridge data, loading unit data, or adapter data) from theother components of the system 6500. For example, the controller 6528may transmit instrument data including a serial number of an attachedadapter (e.g., adapter 6508) attached to the handle 6504, a serialnumber of a loading unit (e.g., loading unit 6514) attached to theadapter, and a serial number of a multi-fire fastener cartridge (e.g.,multi-fire fastener cartridge), loaded into the loading unit, to theconsole 6528. Thereafter, the console 6522 may transmit data (e.g.,cartridge data, loading unit data, or adapter data) associated with theattached cartridge, loading unit, and adapter, respectively, back to thecontroller 6528. The controller 6528 can display messages on the localinstrument display or transmit the message, via transmitter 6506, to theconsole 6522 or the portable device 6526 to display the message on thedisplay 6524 or portable device screen, respectively.

FIG. 15A illustrates an example flow for determining a mode of operationand operating in the determined mode. The computer-implementedinteractive surgical system and/or components and/or subsystems of thecomputer-implemented interactive surgical system may be configured to beupdated. Such updates may include the inclusions of features andbenefits that were not available to the user before the update. Theseupdates may be established by any method of hardware, firmware, andsoftware updates suitable for introducing the feature to the user. Forexample, replaceable/swappable (e.g., hot swappable) hardwarecomponents, flashable firmware devices, and updatable software systemsmay be used to update computer-implemented interactive surgical systemand/or components and/or subsystems of the computer-implementedinteractive surgical system.

The updates may be conditioned on any suitable criterion or set ofcriteria. For example, an update may be conditioned on one or morehardware capabilities of the system, such as processing capability,bandwidth, resolution, and the like. For example, the update may beconditioned on one or more software aspects, such as a purchase ofcertain software code. For example, the update may be conditioned on apurchased service tier. The service tier may represent a feature and/ora set of features the user is entitled to use in connection with thecomputer-implemented interactive surgical system. The service tier maybe determined by a license code, an e-commerce server authenticationinteraction, a hardware key, a username/password combination, abiometric authentication interaction, a public/private key exchangeinteraction, or the like.

At 10704, a system/device parameter may be identified. The system/deviceparameter may be any element or set of elements on which an update inconditioned. For example, the computer-implemented interactive surgicalsystem may detect a certain bandwidth of communication between a modulardevice and a surgical hub. For example, the computer-implementedinteractive surgical system may detect an indication of the purchase ofcertain service tier.

At 10708, a mode of operation may be determined based on the identifiedsystem/device parameter. This determination may be made by a processthat maps system/device parameters to modes of operation. The processmay be a manual and/or an automated process. The process may be theresult of local computation and/or remote computation. For example, aclient/server interaction may be used to determine the mode of operationbased on the on the identified system/device parameter. For example,local software and/or locally embedded firmware may be used to determinethe mode of operation based on the identified system/device parameter.For example, a hardware key, such as a secure microprocessor forexample, may be used to determine the mode of operation based on theidentified system/device parameter.

At 10710, operation may proceed in accordance with the determined modeof operation. For example, a system or device may proceed to operate ina default mode of operation. For example, a system or device may proceedto operate in an alternate mode of operation. The mode of operation maybe directed by control hardware, firmware, and/or software alreadyresident in the system or device. The mode of operation may be directedby control hardware, firmware, and/or software newly installed/updated.

FIG. 15B illustrates an example functional block diagram for changing amode of operation. An upgradeable element 10714 may include aninitialization component 10716. The initialization component 10716 mayinclude any hardware, firmware, and/or software suitable determining amode of operation. For example, the initialization component 10716 maybe portion of a system or device start-up procedure. The initializationcomponent 10716 may engage in an interaction to determine a mode ofoperation for the upgradeable element 10714. For example, theinitialization component 10716 may interact with a user 10730, anexternal resource 10732, and/or a local resource 10718 for example. Forexample, the initialization component 10716 may receive a licensing keyfrom the user 10730 to determine a mode of operation. The initializationcomponent 10716 may query an external resource 10732, such as a serverfor example, with a serial number of the upgradable device 10714 todetermine a mode of operation. For example, the initialization component10716 may query a local resource 10718, such as a local query todetermine an amount of available bandwidth and/or a local query of ahardware key for example, to determine a mode of operation.

The upgradeable element 10714 may include one or more operationcomponents 10720, 10722, 10726, 10728 and an operational pointer 10724.The initialization component 10716 may direct the operational pointer10724 to direct the operation of the upgradable element 10741 to theoperation component 10720, 10722, 10726, 10728 that corresponds with thedetermined mode of operation. The initialization component 10716 maydirect the operational pointer 10724 to direct the operation of theupgradable element to a default operation component 10720. For example,the default operation component 10720 may be selected on the conditionof no other alternate mode of operation being determined. For example,the default operation component 10720 may be selected on the conditionof a failure of the initialization component and/or interaction failure.The initialization component 10716 may direct the operational pointer10724 to direct the operation of the upgradable element 10714 to aresident operation component 10722. For example, certain features may beresident in the upgradable component 10714 but require activation to beput into operation. The initialization component 10716 may direct theoperational pointer 10724 to direct the operation of the upgradableelement 10714 to install a new operation component 10728 and/or a newinstalled operation component 10726. For example, new software and/orfirmware may be downloaded. The new software and or firmware may containcode to enable the features represented by the selected mode ofoperation. For example, a new hardware component may be installed toenable the selected mode of operation.

A surgical hub may be connected, wired or wireless, with various devicesand servers in the operating room, in the medical facility and/oroutside of the medical facility. For example, as shown in FIG. 11,surgical hub 7006 may be capable of communicating with surgicalinstruments 7012, as well as data analytic modules 7034, remoteserver(s) 7013 and/or hub application servers 7002. The surgical hub7006 may communicate with the various devices and servers in differentconnectivity modes, which is described in more detail herein withreference to FIGS. 16A-C.

FIG. 17 shows an example flow for a hub operating under tieredcommunication modes. At 16104, one or more hub connectivity controlparameters may be identified. At 16108, a hub connectivity mode may bedetermined based on the identified hub connectivity controlparameter(s). For example, the surgical hub 7006 shown in FIG. 11 maydetermine the hub connectivity mode based on a hub connectivity controlparameter. The hub connectivity mode may be selected from multipleconnectivity modes that may be preconfigured, dynamically updated,semi-dynamically updated, periodically updated, or preset. The hubconnectivity modes may control inter-device connectivity within anetwork associated with a hospital, and/or communication with anexternal network associated with a different hospital, for example.

The hub connectivity control parameter(s) may include, but not limitedto, systems capabilities such as hardware capability, firmwarecapability and/or software capability. For example, if a surgicalinstrument lacks the hardware capability to provide indications ofinstructional information, the surgical hub may switch to a connectivitymode that may disable providing instructional information to thesurgical instrument.

The hub connectivity control parameter(s) may include aconsumer-controlled parameter, such as a subscription level. Forexample, a medical facility may purchase a subscription to hubconnectivity capabilities. Some subscription level(s) may provide thehub access to surgical data gathered from external systems, while othersmay limit the hub connectivity to internal devices.

The hub connectivity control parameter(s) may include available databandwidth, power capacity and usage, processor and memory utilization,and/or internal or attached systems.

The hub connectivity control parameter(s) may include an indication froma tiered system. The tiered system may scale the communication betweenthe surgical hub 7006 and the device(s) 7012, the communication betweenthe surgical hub 7006 and external server(s) 7013/7002 and/or the like,based on the available data bandwidth, power capacity and usage,processor and memory utilization, and/or internal or attached systems.The tiered system may determine max communication capabilities thesurgical hub may operate under. For example, upon detecting the powercapability associated with the operation room, associated with thesurgical hub, and/or associated with a medical facility is below athreshold, the tiered system may scale down the surgical hub'sconnectivity capabilities. For example, upon detecting available databandwidth is below a threshold, memory utilization is above a certainthreshold, power usage is above a certain threshold, and/or other systemconditions that may warrant scaling down the surgical hub's connectivitycapabilities, the tiered system may limit or disable the communicationbetween the surgical hub and the devices and/or the communicationbetween the surgical hub and external server(s). For example,bi-directional connectivity mode (as shown in FIG. 16B) may be scaleddown to flow-through connectivity mode (as shown in FIG. 16A). Externalcommunications (as shown in FIG. 16) may be disabled. In examples, thetiered system may be a module within the surgical hub or may be a systemexternal to the surgical hub.

At 16110, the surgical hub may communicate with devices in the operatingroom, servers in the internal and/or external network(s) in accordancewith the determined hub connectivity mode.

In an example hub connectivity mode, the surgical hub may receiveinformation from surgical instrument(s) and may send the receivedinformation to a remote server (such as a remote processing serverand/or a remote database in the cloud).

In an example connectivity mode, the surgical hub may receiveinformation from surgical instrument(s) and may send the receivedinformation to a remote server (such as a remote processing serverand/or a remote database in the cloud). The surgical hub may receiveinformation from surgical instrument(s), obtain instructionalinformation based on the information received from the surgicalinstrument(s), and may send the instructional information to one or moresurgical instrument(s).

In an example connectivity mode, the surgical hub may receiveinformation from surgical instrument(s) and may send the receivedinformation to a remote server (such as a remote processing serverand/or a remote database in the cloud). The surgical hub may receiveinformation from surgical instrument(s), obtain instructionalinformation based on the information received from the surgicalinstrument(s), and may send the instructional information to one or moresurgical instrument(s). The surgical hub may record various surgicalinformation and send surgical information to a remote server forarchiving and/or analysis. The archived surgical information may beaggregated with information received from other surgical hub(s), and/orsurgical information associated with other medical facilities. Theaggregated information may be accessed to generate instructionalinformation to one or more surgical instrument(s). In an example, thesurgical communication hub may aggregate information, such asinformation received from smart surgical devices, information associatedwith multiple surgeries, surgical information and corresponding outcomeassociated with multiple patients. The aggregated information may bestored in a remote database. In an example, the surgical information maybe aggregated at a remote server.

FIGS. 16A-C illustrate example hub connectivity modes that a surgicalhub, such as the surgical hub 7006 may operate under. As shown in FIGS.16A-C, the surgical hub 15504 may communicate with the various devices15506, remote server(s) in the cloud 15502 and/or devices, servers anddatabases in external networks 15508 in different connectivity modes.

For example, the surgical hub may determine to operate in a connectivitymode where surgical information may flow through the surgical hub to aremote server. As shown in FIG. 16A, the surgical hub 15504 may serve asa communication portal between the local devices/systems (e.g., surgicalinstruments and other equipment within the operating room) 15506 and theother connected systems 15502, including systems local or remote to thesurgical hub. In this flow-through connectivity mode, the surgical hub15504 may act as a communication bus between different devices andsystems, enabling them to communicate via the surgical hub.

The surgical hub 15504 may receive surgical information data from one ormore smart surgical devices 15506 in the operating room, for example, asdescribed herein with reference to FIG. 13. As shown in FIG. 13, thesurgical hub 9000 may receive surgical data associated with a surgicalprocedure being performed in the surgical operating room from themodular surgical device(s) 9050.

During a surgical procedure, surgical devices 9050 may track and recordsurgical data and variables (e.g., surgical parameters). The surgicalparameters may include force-to-fire (FTF), force-to-close (FTC), firingprogress, tissue gap, power level, impedance, tissue compressionstability (creep), and/or the like.

The surgical devices 9050 may include an end effector including a staplecartridge. The captured surgical data may include snapshots taken via anendoscope of the surgical hub during a stapling portion of a surgicalprocedure. The surgical devices 9050 may include a temperature sensor.The captured surgical data may include least one temperature detected bythe temperature sensor during a tissue sealing portion of a surgicalprocedure.

For example, when operating under flow-through connectivity mode, thesurgical hub 15504 may disable interpretation, control or operation onthe received information. The surgical hub 15504 may determine whetherto disable obtaining instructional information based on the connectivitymode. Based on a determination that the current connectivity mode is aflow-through mode, the surgical hub 15504 may disable obtaininginstructional information.

In an example hub connectivity mode, the surgical hub may generateinstructional information based on the received surgical data.

FIG. 18A shows an example flow for operating under variable hubcommunication modes. As shown in FIG. 18A, at 16182, a hub connectivitymode may be determined based on the identified hub connectivity controlparameter(s) as described herein. At 16184, whether the hub connectivitymode indicates the hub may provide instructional information to surgicaldevices may be determined. For example, the surgical hub 5104 asdescribed with respect to FIG. 9 may determine whether to provideinstructional information to at least one smart surgical device 5102based on the hub connectivity mode. On a condition that the hubconnectivity mode does not support provisioning instructionalinformation to surgical devices, at 16188, provisioning instructionalinformation to surgical devices may be disabled. On a condition that thehub connectivity mode supports provisioning instructional information tosurgical devices, at 16186, the surgical hub may determine to obtain andprovide instructional information to surgical devices.

The surgical hub may obtain instructional information to surgicaldevices based at least in part on surgical data received from one ormore surgical devices. For example, based on a determination that thecurrent hub connectivity mode is a bi-directional mode, the surgical hubmay receive surgical data from a surgical device and may obtain aresponse to the surgical device based on the received surgical data.Based on a determination that the current hub connectivity mode is abi-directional mode, the surgical hub may receive surgical data from afirst device and may obtain an indication to a second device based onthe surgical data received from the first device. The indication to thesecond device may include the surgical data received from the firstdevice and/or other information.

FIG. 16B shows an example bi-directional mode. As shown, the surgicalhub 15506 may receive surgical data from surgical device(s) 15506, andmay send data, such as instructional information to device(s) 15506. Thesurgical hub 15506 may aggregate the surgical data received fromsurgical device(s) 15506 prior to sending to the remote server(s) in thecloud 15502.

In an example, the surgical data received by the surgical hub and sentto the remote server(s) may include a property of airborne particles ina fluid within a patient's abdominal cavity, such as a particle type,particle size, particle concentration, particle velocity, and/orparticle direction. The instructional information that the surgical hubobtains based on the received surgical data may include, but not limitedto, an adjustment to a surgical function, such as proportionatelyincreasing the surgical function based on the property of airborneparticles in the fluid, adding a supplemental surgical function to thesurgical function, adjusting the power level provided to an energydevice, adjusting the speed of a pump in a smoke evacuator, adjusting aflow path through the filtering system of the smoke evacuator, adjustingthe operating room vent to increase ventilation therethrough, adjustinga degree of the activation of an actuator, and/or replacing the surgicalfunction with an alternative surgical function.

In examples, the instructional information that the surgical hub obtainsbased on the received surgical data may include, but not limited to,prioritization information (e.g., display prioritization information),cartridge usage or selection recommendation, a warning message and/orsurgical device usage instructions.

For example, when the current hub connectivity mode is a bi-directionalmode, the surgical hub may determine to obtain and provide instructionalinformation. An example bi-directional connectivity mode may enablesituational awareness and controlling surgical device(s). The surgicalhub may infer progression of the surgical procedure from the surgicaldata and may obtain instructional information based on the inferredprogression of the surgical procedure. The surgical hub may assess asurgical activity performed by an end effector of the modular surgicaldevice at the surgical site from the data extracted from the at leastone image frame.

For example, as shown in FIG. 9, the surgical hub 5104 may receiveperioperative data from the devices 5102 and other data sources (e.g.,databases 5122 and patient monitoring devices 5124) that arecommunicably coupled to the surgical hub 5706. The surgical hub 5104 maydetermine whether an event has occurred based on the received data. Theevent can include, for example, a surgical procedure, a step or portionof a surgical procedure, or downtime between surgical procedures orsteps of a surgical procedure. The surgical hub 5104 may track dataassociated with the particular event, such as the length of time of theevent, the surgical instruments and/or other medical products utilizedduring the course of the event, and the medical personnel associatedwith the event. The surgical hub 5104 may determine event data via, forexample, the situational awareness processes as described herein.

The surgical hub 5104 may provide the devices 5102 with instructionalinformation such as, but not limited to, control adjustment information,prioritization information, warning, display instructions. For example,the surgical hub 5104 may receive surgical data that may includeperioperative data detected by one or more smart surgical devices 5102during a surgical procedure. The surgical hub 5104 may determinecontextual information regarding the surgical procedure according to theperioperative data. The surgical hub may obtain control adjustments forone or more surgical devices 5102 based on the contextual information.The perioperative data include one or more parameter associated with themodular device and/or one or more parameter associated with a patient.

The instructional data information be provided to a surgical device withan associated priority. The instructional information that the surgicalhub obtains based on the received surgical data may includerecommendation to a clinician in an operating room. The recommendationmay be provided to a surgical device with a priority that may bedetermined by the surgical hub. For example, an elevated priority levelmay be communicated with at least one of marking, emphasizing,highlighting, or flashing. For example, the surgical hub may determine asurgical state based on the received surgical data and may determine thepriority level of the recommendation based on the surgical state. Forexample, the surgical hub 5104 may determine a surgical state based onthe received surgical data. The surgical state may include, a step in asurgical procedure, identification of a suite of surgical devicescurrently in use in a surgical theater, a position of a portion of thesurgical device, a position of a jaw of an end effector of the surgicaldevice, a gross usage surgical step, and/or a precision usage surgicalstep.

The surgical hub may select one or more recommendations from multiplepossible recommendations based on the surgical state. The priority levelof the recommendation may be adjusted based on an anticipated surgicalaction. The anticipated surgical action may be determined based on thesurgical state, and/or based on a position of a surgical device at asurgical site.

Situational awareness processes are described in greater detail in U.S.patent application Ser. No. 15/940,654 (Attorney Docket No.END8501USNP), titled SURGICAL HUB SITUATIONAL AWARENESS, filed Mar.29,2018; U.S. patent application Ser. No. 16/209,478 (Attorney DocketNo. END9015USNP1), titled METHOD FOR SITUATIONAL AWARENESS FOR SURGICALNETWORK OR SURGICAL NETWORK CONNECTED DEVICE CAPABLE OF ADJUSTINGFUNCTION BASED ON A SENSED SITUATION OR USAGE, filed Dec. 4,2018; andU.S. patent application Ser. No. 16/182,246 (Attorney Docket No.END9016USNP1), titled ADJUSTMENTS BASED ON AIRBORNE PARTICLE PROPERTIES,filed Nov. 6, 2018; the disclosure of each is herein incorporated byreference in its entirety.

Surgical procedures are performed by different surgeons at differentlocations, some with much less experience than others. For a givensurgical procedure, there may be many parameters that can be varied toattempt to realize a desired outcome. For example, for a given surgicalprocedure which utilizes energy supplied by a generator, the surgeonoften relies on experience alone for determining which mode of energy toutilize, which level of output power to utilize, the duration of theapplication of the energy, etc., in order to attempt to realize thedesired outcome. To increase the likelihood of realizing desiredoutcomes for different surgical procedures, a surgeon may be providedwith best practice recommendations, which may be generated based onaggregated surgical data sets associated with multiple surgicalprocedures performed in multiple locations over time.

As shown in FIG. 18B, at 16202, a hub connectivity mode may bedetermined based on the identified hub connectivity control parameter(s)as described herein. At 16204, whether the determined hub connectivitymode supports data aggregation with external sources may be determined.For example, the hub may determine whether to send recorded surgicalinformation associated with a procedure to a remote server for archivingand potential aggregation with data associated with external network(s)based on the hub connectivity mode. If the determined hub connectivitymode supports data aggregation with external sources, at 16206, thesurgical hub may send recorded surgical information to a remote server.For example, the surgical hub may enable communication to externalsystem(s) when operating in a certain connectivity mode. Based on adetermination to send recorded surgical information to a remote server,surgical data may be sent to an external hub associated with an externalnetwork (e.g., a different medial facility, a different hospital, or thelike).

FIG. 16C shows an example hub connectivity mode that supports dataaggregation with external data sets. As shown, the surgical hub 15506may receive surgical data from surgical device(s) 15506, and may senddata, such as instructional information to device(s) 15506. The surgicalhub 15504 may facilitate recording and archiving surgical data and mayexchange surgical data and/or related analysis with an externalnetwork(s) 15508. Data from various hospitals or medical organizations15508 can be aggregated. Surgical data, outcome, patient information canbe compiled to determine instructional information, surgicalrecommendations, aggregation analysis, and/or the like. As shown, thesurgical hub 15504 may retrieve aggregation analysis from remoteserver(s) or database(s) in the cloud 15502. The aggregation analysismay be used to generate instructional information for sending tosurgical devices 15506.

As shown in FIG. 18B, the surgical hub may determine whether to disablecommunication to an external system based on the hub connectivity mode.If the determined hub connectivity mode does not support dataaggregation with external sources, at 16208, sending recorded surgicalinformation for aggregation with external sources may be disabled. Forexample, the surgical hub may disable communication to externalsystem(s) when operating under certain connectivity modes, such as theflow-through connectivity mode and the bi-directional connectivity modedescribed herein.

Recording surgical data is described in greater detail in U.S. patentapplication Ser. No. 16/209,385 (Attorney Docket No. END8495USNP),titled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY,filed Dec. 4, 2018, the disclosure of which is herein incorporated byreference in its entirety. The recorded surgical data may includesurgical event data as described herein. Surgical event data, forexample, recorded and/or aggregated surgical event data may be sent to aremote server for aggregation with surgical data from external networksand for further analysis.

Examples of aggregation (e.g., remote aggregation), requests andanalysis are described in detail in U.S. patent application Ser. No.15/940,668 titled AGGREGATION AND REPORTING OF SURGICAL HUB DATA;Attorney Docket No. END8501USNP2, filed on Mar. 29, 2018, which isherein incorporated by reference in its entirety.

When operating in a connectivity mode that allows externalcommunication, the surgical hub may request information from a remoteserver and/or external systems. As shown in FIG. 18C, at 16302, a hubconnectivity mode may be determined based on the identified hubconnectivity control parameter(s) as described herein. At 16304, the hubmay determine whether to retrieve aggregation analysis from the remoteserver based on the hub connectivity mode. Based on a determination thatthe current hub connectivity mode supports remote data aggregation andanalysis, at 16308, the surgical hub may generate an aggregationanalysis request. The request may be generated based on the receivedsurgical data and may be sent to a remote server at 16310. For example,the aggregation analysis request may indicate a request forrecommendation on generator data associated with a particular step in asurgical procedure. In response, the surgical hub may receive anaggregation analysis response from the remote server at 16312.

For example, the aggregation analysis response may include arecommendation and/or a report. The aggregation analysis response mayinclude one or more of: an energy mode of the generator for a particularsurgical procedure, a power output of the generator for a particularsurgical procedure, and/or a duration of the power output of thegenerator for a particular surgical procedure. The aggregation analysisresponse may include instructional information as described herein. At16314, the surgical hub may generate and send instructional informationto one or more surgical device(s) based on the received aggregationanalysis response. As shown in FIG. 18C, based on a determination thatthe current hub connectivity mode supports remote data aggregationanalysis, the surgical hub may disable data aggregation analysisrequests at 16306.

FIG. 19 is a block diagram of a computer-implemented interactivesurgical system 5700, in accordance with at least one aspect of thepresent disclosure. The system 5700 may include a number of surgicalhubs 5706 that, as described herein, may detect and track data relatedto surgical procedures that the surgical hubs 5706 (and the modulardevices paired to the surgical hubs 5706) are utilized in connectionwith. The surgical hubs 5706 may be connected to form local networkssuch that the data being tracked by the surgical hubs 5706 is aggregatedtogether across the network. The networks of surgical hubs 5706 can beassociated with a medical facility, for example. The data aggregatedfrom the network of surgical hubs 5706 can be analyzed to providereports on data trends or recommendations. For example, the surgicalhubs 5706 of a first medical facility 5704 a may be communicablyconnected to a first local database 5708 a and the surgical hubs 5706 ofa second medical facility 5704 b are communicably connected to a secondlocal database 5708 b. The network of surgical hubs 5706 associated withthe first medical facility 5704 a can be distinct from the network ofsurgical hubs 5706 associated with the second medical facility 5704 b,such that the aggregated data from networks of surgical hubs 5706 maycorrespond to medical facility 5704 a, 5704 b individually. A surgicalhub 5706 or another computer terminal communicably connected to thedatabase 5708 a, 5708 b can be configured to provide reports orrecommendations based on the aggregated data associated with therespective medical facility 5704 a, 5704 b. The data tracked by thesurgical hubs 5706 can be utilized to, for example, report whether aparticular incidence of a surgical procedure deviated from the averagein-network time to complete the particular procedure type.

The surgical hub 5706 may upload the tracked data to the cloud 5702, forprocessing and aggregating the tracked data across multiple surgicalhubs 5706, networks of surgical hubs 5706, and/or medical facilities5704 a, 5704 b that are connected to the cloud 5702. The surgical hub5706 may provide reports or recommendations based on the aggregateddata. The data tracked by the surgical hubs 5706 can be utilized to, forexample, report whether a particular incidence of a surgical proceduredeviated from the average global time to complete the particularprocedure type.

The surgical hub 5706 can be configured to access the cloud 5702 tocompare locally tracked data to global data aggregated from the surgicalhubs 5706 that are communicably connected to the cloud 5702. Thesurgical hub 5706 may provide reports or recommendations based on thecomparison between the tracked local data relative to local (e.g.,in-network) or global norms. The data tracked by the surgical hubs 5706can be utilized to, for example, report whether a particular incidenceof a surgical procedure deviated from either the average in-network timeor the average global time to complete the particular procedure type.

The surgical hub 5706 or a computer system local to the surgical hub5706 may locally aggregate the data tracked by the surgical hubs 5706,store the tracked data, and generate reports and/or recommendationsaccording to the tracked data in response to queries. In cases where thesurgical hub 5706 is connected to a medical facility network (which mayinclude additional surgical hubs 5706), the surgical hub 5706 maycompare the tracked data with the bulk medical facility data. The bulkmedical facility data can include EMR data and aggregated data from thelocal network of surgical hubs 5706. The cloud 5702 (e.g., a remoteserver in the cloud) may aggregate the data tracked by the surgical hubs5706, store the tracked data, and generate reports and/orrecommendations according to the tracked data in response to queries.

The surgical hub 5706 can provide reports regarding trends in the dataand/or provide recommendations on improving the efficiency oreffectiveness of the surgical procedures being performed. The datatrends and recommendations can be based on data tracked by the surgicalhub 5706 itself, data tracked across a local medical facility networkcontaining multiple surgical hubs 5706, and/or data tracked across anumber of surgical hubs 5706 communicably connected to a cloud 5702. Therecommendations provided by the surgical hub 5706 can describe, forexample, particular surgical instruments or product mixes to utilize forparticular surgical procedures based on correlations between thesurgical instruments/product mixes and patient outcomes and proceduralefficiency. The reports provided by the surgical hub 5706 can describe,for example, whether a particular surgical procedure was performedefficiently relative to local or global norms, whether a particular typeof surgical procedure being performed at the medical facility is beingperformed efficiently relative to global norms, and the average timetaken to complete a particular surgical procedure or step of a surgicalprocedure for a particular surgical team.

The surgical hub 5706 may determine when operating theater events occur(e.g., via a situational awareness module/system) and track the lengthof time spent on each event. An operating theater event is an event thata surgical hub 5706 can detect or infer the occurrence of. An operatingtheater event can include, for example, a particular surgical procedure,a step or portion of a surgical procedure, or downtime between surgicalprocedures. The operating theater events can be categorized according toan event type, such as a type of surgical procedure being performed, sothat the data from individual procedures can be aggregated together toform searchable data sets. The data tracked by the surgical hubs 5706being parsed to provide metrics related to surgical procedures or theuse of the surgical hub 5706.

The surgical hub 5706 may determine whether a surgical procedure isbeing performed and then track both the length of time spent betweenprocedures (e.g., downtime) and the time spent on the proceduresthemselves. The surgical hub 5706 can determine and track the time spenton the individual steps taken by the medical personnel (e.g., surgeons,nurses, orderlies) either between or during the surgical procedures. Thesurgical hub may determine when surgical procedures or different stepsof surgical procedures are being performed via a situational awarenessmodule/system as described in herein.

Near-field-communication (NFC) cards may be used to automate supplychain. FIG. 20 illustrates an example surgical supply packaged with aradio frequency identification (RFID) NFC chip. As shown, surgicalsupply 16510 may include surgical devices, sutures, biosurgery supply,and/or the like. Medical personnel may scan the chip 16530 on thesurgical supply 16510 prior to introduction to surgery. This may allowthe supply chain for customers ordering and may provide full case deviceprofiles, for example, via cloud 16520. NFC reader may be used to trackinventory, for example, by adding an RFID card 16530 into devices orpackaging.

EXAMPLES OF THE DISCLOSURE

The following is a non-exhaustive list of embodiments describedhereinabove and/or shown in the drawings, and which may be claimedhereinafter:

Example 1. A surgical hub comprising

-   -   a receiver configured to: receive surgical information from at        least one smart surgical device;    -   a transmitter configured to: send surgical data to a remote        server;    -   a processor configured to:        -   determine a hub connectivity mode based on a hub            connectivity control parameter;        -   determine whether to send instructional information to the            at least one smart device based on the hub connectivity            mode; and        -   communicate with the at least one smart device based on the            determination.

The surgical hub according to Example 1 may be the surgical hub as shownin FIG. 11 and described above, though alternative configurations ofsurgical hub are also envisaged. The surgical hub may operate under oneof the exemplary hub connectivity modes shown in FIGS. 16A-C, thoughalternative connectivity modes are also envisaged. Irrespective of theparticular configuration, a surgical hub may communicate with variousdevices, remote server(s), and/or devices, servers and databases inexternal networks in different connectivity modes. The communicationallows the hub to communicate to and from these devices, aggregateinformation and then communicate to and from a remote processing serveror database.

The hub connectivity mode recited in Example 1 may be selected frommultiple connectivity modes that may be preconfigured, dynamicallyupdated, semi-dynamically updated, periodically updated, or preset. Thehub connectivity modes may control inter-device connectivity within anetwork associated with a medical facility, e.g. a hospital, and/orcommunication with an external network associated with a differenthospital. In Example 1, the hub connectivity mode is determined based ona hub connectivity control parameter.

The hub connectivity control parameter(s) may include, but not limitedto, systems capabilities such as hardware capability, firmwarecapability and/or software capability. The hub connectivity controlparameter(s) may include a consumer-controlled parameter, such as asubscription level. The hub connectivity control parameter(s) mayinclude an indication from a tiered system. The tiered system may scalethe communication between the surgical hub and the device(s), thecommunication between the surgical hub and external server(s) and/or thelike, based on the available data bandwidth, power capacity and usage,processor and memory utilization, and/or internal or attached systems.The tiered system may determine max communication capabilities thesurgical hub may operate under.

The surgical hub of Example 1 may operate in a flow-through connectivitymode, where surgical information may flow through the surgical hub to aremote server. The surgical hub may operate in a bi-directional mode inwhich the surgical hub may receive surgical data from surgical device(s)and send data, such as instructional information to device(s). In anexemplary bi-directional mode, the surgical hub may aggregate thesurgical data received from surgical device(s) prior to sending to theremote server(s) in the cloud. The bi-directional mode may enablesituational awareness and controlling surgical device(s). The surgicalhub may operate in a hub connectivity mode that supports dataaggregation with external data sets. In this hub connectivity mode, thesurgical hub may facilitate recording and archiving surgical data andmay exchange surgical data and/or related analysis with an externalnetwork(s). Data from various hospitals or medical organizations can beaggregated. Surgical data, outcome, patient information can be compiledto determine instructional information, surgical recommendations,aggregation analysis, and/or the like. The surgical hub may retrieveaggregation analysis from remote server(s) or database(s) in a cloud.Aggregation analysis increases the likelihood of realizing desiredoutcomes for different surgical procedures. A surgeon may be providedwith best practice recommendations, which may be generated based onaggregated surgical data sets associated with multiple surgicalprocedures performed in multiple locations over time.

EXAMPLES OF THE DISCLOSURE

In Example 1, the surgical hub determines, based on the hub connectivitymode, whether to provide instructional information to at least onesurgical instrument in communication with the surgical hub. This allowsthe surgical hub to take selective actions with regarding to providinginstructional information to the at least one surgical instrumentaccording to a condition of hub connectivity mode. For instance, on acondition that the hub connectivity mode does not support provisioninginstructional information to surgical devices, provisioninginstructional information to surgical devices may be disabled. This maybe the case when the hub connectivity control parameter(s) indicates alack of hardware capability in the surgical instrument to provideindications of instructional information, the surgical hub may switch toa connectivity mode that may disable providing instructional informationto the surgical instrument. On the other hand, on a condition that thehub connectivity mode supports provisioning instructional information tosurgical devices, the surgical hub may determine to obtain and provideinstructional information to surgical devices.

Example 2. The surgical hub of Example 1, wherein the transmitter isfurther configured to send data to the at least one smart surgicaldevice, and the processor is further configured to:

-   -   based on a determination to send instructional information,        obtain instructional information based on the received surgical        information; and    -   send the obtained instructional information to the at least one        smart surgical device via the transmitter.

Example 2 relates to a condition in which the hub connectivity modesupports provisioning instructions to surgical devices. The surgicaldevices are therefore provided with instructions, which may includeinstructions taking consideration of the situational awareness, historicinformation, etc. Depending on the instructional information provided,the outcome and quality of the surgical activities performed by thesurgical device may be improved. The surgeon may be provided withwarning messages, and/or recommendations in relation to the device,patient and procedure. Operation of the device may be improved. Thesafety of the patient may be safeguarded.

Example 3. The surgical hub of Example 1 or 2, wherein the instructionalinformation comprises at least one of:

-   -   an adjustment to a surgical function;    -   prioritization information;    -   a cartridge usage recommendation;    -   a warning message;    -   surgical device usage recommendations; or    -   surgical device usage instructions.

Example 3 relates to specific instructional information that may beprovided to the device and/or the surgeon, which may contribute to theimprovement of efficiency and/or effectiveness of a surgical function,and/or safety and security of operation.

Example 4. The surgical hub of any preceding Example, wherein theprocessor is further configured to: determine whether to disablecommunication with an external system based on the hub connectivitymode.

Example 4 relates to control of communication with an external systembased on the hub connectivity mode. For example, in a condition that thehub connectivity mode does not support access to external systems asdetermined by the hub connectivity control parameter, which may includea consumer-controlled parameter, such as a subscription level,communication of the surgical hub with an external system may bedisabled. This may be the case when a medical facility purchases asubscription to hub connectivity capabilities and the subscriptionlevel(s) limit the hub connectivity to internal devices.

Example 5. The surgical hub of any preceding Example, wherein theprocessor is further configured to: determine whether to send recordedsurgical information associated with a procedure to the remote serverbased on the hub connectivity mode.

Surgical instruments or the surgical hub may record surgical informationassociated with a procedure while the procedure is performed. Example 5relates to control of the surgical hub to send recorded surgicalinformation received from the surgical instrument to the remote serverfor archiving and/or analysis. The archived surgical information may beaggregated with information received from other surgical hub(s), and/orsurgical information associated with other medical facilities. Theaggregated information may be accessed to generate instructionalinformation to one or more surgical instrument(s). In an example, thesurgical communication hub may aggregate information, such asinformation received from smart surgical devices, information associatedwith multiple surgeries, surgical information and corresponding outcomeassociated with multiple patients. The aggregated information may bestored in a remote database. In an example, the surgical information maybe aggregated at a remote server.

Example 6. The surgical hub of any preceding Example, wherein thereceiver is further configured to: receive data from the remote server,and the processor is further configured to:

-   -   determine whether to retrieve aggregation analysis from the        remote server based on the hub connectivity mode;    -   based on a determination to retrieve the aggregation analysis,        generate an aggregation analysis request based on the received        surgical data;    -   send the aggregation analysis request to the remote server via        the transmitter;    -   receive an aggregation analysis response from the remote server        via the receiver;    -   generate the instructional information based on the aggregation        analysis response; and send the instructional information to the        at least one smart device via the transmitter.

Example 6 relates to aggregation analysis. In Example 6, the surgicalhub is enabled to retrieve aggregation analysis from the remote serverand provide instructional information, such as trends in the surgicaldata and/or recommendations based on aggregation analysis, to thesurgical device. For example, the remote server may aggregateinformation received from surgical hub(s), and/or surgical informationassociated with other medical facilities. The aggregated information maybe accessed to generate instructional information to one or moresurgical instrument(s). Aggregation analysis increases the likelihood ofrealizing desired outcomes for different surgical procedures. A surgeonmay be provided with best practice recommendations, which may begenerated based on aggregated surgical data sets associated withmultiple surgical procedures performed in multiple locations over time

Example 7. The surgical hub of any preceding Example, wherein the hubconnectivity control parameter comprises at least one of: available databandwidth, power capacity associated with the surgical hub, powercapacity associated with an operating room, power capacity associatedwith a medical facility, a power usage, processor utilizationinformation, or memory utilization information.

The hub connectivity control parameter as specified in Example 7 allowsthe hub connectivity mode to control the communication of the surgicalhub with the surgical instruments and/or the external server based onthe condition of the data bandwidth, power, and/or processor and memoryutilization information.

Example 8. The surgical hub of any one of Examples 1-6, wherein the hubconnectivity control parameter comprises at least one of: a subscriptionlevel associated with hub connectivity, a user preference associatedwith hub connectivity, or an indication from a tiered software controlsystem.

The hub connectivity control parameter as specified in Example 8 allowsthe hub connectivity mode to control or scale down the communication ofthe surgical hub with the surgical instruments and/or the externalserver based on the subscription level, user preference or an indicationfrom a tiered software control system. For instance, when the hubconnectivity control parameter(s) include an indication from a tieredsystem, the tiered system may scale the communication between thesurgical hub and the surgical instrument, the communication between thesurgical hub and the external server, based on, for example, theavailable data bandwidth, power capacity and usage, processor and memoryutilization, and/or internal or attached systems. The tiered system maydetermine max communication capabilities the surgical hub may operateunder. For example, upon detecting the power capability associated withthe operation room, associated with the surgical hub, and/or associatedwith a medical facility is below a threshold, the tiered system mayscale down the surgical hub's connectivity capabilities. For anotherexample, upon detecting available data bandwidth is below a threshold,memory utilization is above a certain threshold, power usage is above acertain threshold, and/or other system conditions that may warrantscaling down the surgical hub's connectivity capabilities, the tieredsystem may limit or disable the communication between the surgical huband the at least one surgical instrument and/or the communicationbetween the surgical hub and the external server. For example, thebi-directional connectivity mode (as shown in FIG. 16B) may be scaleddown to flow-through connectivity mode (as shown in FIG. 16A). Externalcommunications (as shown in FIG. 16) may be disabled.

Example 9. A method for controlling hub connectivity, the methodcomprising:

-   -   receiving surgical information from at least one smart surgical        device;    -   determining a hub connectivity mode based on a hub connectivity        control parameter;    -   determining whether to send instructional information to the at        least one smart device based on the hub connectivity mode; and    -   communicating with the at least one smart device based on the        determination.

Example 10. The method of Example 9, further comprising:

-   -   based on a determination to send instructional information,        obtaining instructional information based on the received        surgical information; and    -   sending the obtained instructional information to the at least        one smart surgical device.

Example 11. The method of Example 9 or 10, wherein the instructionalinformation comprises at least one of:

-   -   an adjustment to a surgical function;    -   prioritization information;    -   a cartridge usage recommendation;    -   a warning message;    -   surgical device usage recommendations; or    -   surgical device usage instructions.

Example 12. The method of any one of Examples 9-11, further comprising:determining whether to disable communication with an external systembased on the hub connectivity mode.

Example 13. The method of any one of Examples 9-12, further comprising:determining whether to send recorded surgical information associatedwith a procedure to a remote server based on the hub connectivity mode.

Example 14. The method of any one of Examples 9-13, further comprisingreceiving data from a or the remote server, and the processor is furtherconfigured to: determining whether to retrieve aggregation analysis fromthe remote server based on the hub connectivity mode;

-   -   based on a determination to retrieve the aggregation analysis,        generating an aggregation analysis request based on the received        surgical data;    -   sending the aggregation analysis request to the remote server        via a transmitter of the hub;    -   receiving an aggregation analysis response from the remote        server via a receiver of the hub;    -   generating the instructional information based on the        aggregation analysis response; and    -   sending the instructional information to the at least one smart        device via the transmitter.

Example 15. The method of any one of Examples 9-14, wherein the hubconnectivity control parameter comprises at least one of: available databandwidth, power capacity associated with the surgical hub, powercapacity associated with an operating room, power capacity associatedwith a medical facility, a power usage, processor utilizationinformation, or memory utilization information.

Example 16. The method of any one of Examples 9-14, wherein the hubconnectivity control parameter comprises at least one of: a subscriptionlevel associated with hub connectivity, a user preference associatedwith hub connectivity, or an indication from a tiered software controlsystem.

The methods of Examples 9-16 may be performed by a surgical hub.

Example 17. A computer readable medium comprising instructions storedtherein, when executed, performing:

-   -   receiving surgical information from at least one smart surgical        device;    -   determining a hub connectivity mode based on a hub connectivity        control parameter;    -   determining whether to send instructional information to the at        least one smart device based on the hub connectivity mode; and    -   communicating with the at least one smart device based on the        determination.

Example 18. The computer readable medium of claim 17, further comprisinginstructions when executed by the processor of the surgical hub,performing:

-   -   based on a determination to send instructional information,        obtaining instructional information based on the received        surgical information; and    -   sending the obtained instructional information to the at least        one smart surgical device.

Example 19. The computer readable medium of Example 17 or 18 furthercomprising instructions when executed by the processor of the surgicalhub performing: determining whether to disable communication with anexternal system based on the hub connectivity mode.

Example 20. The computer readable medium of any one of Examples 17-19,further comprising instructions when executed by the processor of thesurgical hub performing:

-   -   determining whether to send recorded surgical information        associated with a procedure to the remote server based on the        hub connectivity mode.

The instructions on the computer readable mediums of Examples 17-20 maybe executed by a processor of a surgical hub.

The methods according to Examples 9-16, and the computer readablemediums as described in Examples 17-19, correspond to the apparatuses ofExamples 1-8. The above discussion in relation to Examples 1-8 thereforealso apply to Examples 9-20.

Example 21. The surgical hub, the method, or the computer readablemedium of any preceding Example, wherein the hub connectivity mode isselectable from a plurality of connectivity modes under which thesurgical hub may operate, wherein each of the hub connectivity modes isconfigured to control inter-device connectivity within a network, and/orcommunication with an external network.

Example 22. The surgical hub, the method, or the computer readablemedium of any preceding Example, wherein the surgical information fromthe at least one smart surgical device comprises surgical dataassociated with a surgical procedure performed by the at least one smartsurgical device, wherein, optionally, the surgical data and surgicalparameters are recorded by the at least one surgical device during thesurgical procedure, and further optionally, the surgical parameterincluding at least one of force-to-fire, force-to-close, firingprogress, tissue gap, power level, impedance, and tissue compressionstability.

1. A surgical hub comprising: a receiver configured to: receive surgicalinformation from at least one smart surgical device; a transmitterconfigured to: send surgical data to a remote server; a processorconfigured to: determine a hub connectivity mode based on a hubconnectivity control parameter; determine whether to send instructionalinformation to the at least one smart device based on the hubconnectivity mode; and communicate with the at least one smart devicebased on the determination.
 2. The surgical hub of claim 1, wherein thetransmitter is further configured to send data to the at least one smartsurgical device, and the processor is further configured to: based on adetermination to send instructional information, obtain instructionalinformation based on the received surgical information; and send theobtained instructional information to the at least one smart surgicaldevice via the transmitter.
 3. The surgical hub of claim 1, wherein theinstructional information comprises at least one of: an adjustment to asurgical function; prioritization information; a cartridge usagerecommendation; a warning message; surgical device usagerecommendations; or surgical device usage instructions.
 4. The surgicalhub of claim 1, wherein the processor is further configured to:determine whether to disable communication with an external system basedon the hub connectivity mode.
 5. The surgical hub of claim 1, whereinthe processor is further configured to: determine whether to sendrecorded surgical information associated with a procedure to the remoteserver based on the hub connectivity mode.
 6. The surgical hub of claim1, wherein the receiver is further configured to: receive data from theremote server, and the processor is further configured to: determinewhether to retrieve aggregation analysis from the remote server based onthe hub connectivity mode; based on a determination to retrieve theaggregation analysis, generate an aggregation analysis request based onthe received surgical data; send the aggregation analysis request to theremote server via the transmitter; receive an aggregation analysisresponse from the remote server via the receiver; generate theinstructional information based on the aggregation analysis response;and send the instructional information to the at least one smart devicevia the transmitter.
 7. The surgical hub of claim 1, wherein the hubconnectivity control parameter comprises at least one of: available databandwidth, power capacity associated with the surgical hub, powercapacity associated with an operating room, power capacity associatedwith a medical facility, a power usage, processor utilizationinformation, or memory utilization information.
 8. The surgical hub ofclaim 1, wherein the hub connectivity control parameter comprises atleast one of: a subscription level associated with hub connectivity, auser preference associated with hub connectivity, or an indication froma tiered software control system.
 9. A method for controlling hubconnectivity, the method comprising: receiving surgical information fromat least one smart surgical device; determining a hub connectivity modebased on a hub connectivity control parameter; determining whether tosend instructional information to the at least one smart device based onthe hub connectivity mode; and communicating with the at least one smartdevice based on the determination.
 10. The method of claim 9, furthercomprising based on a determination to send instructional information,obtaining instructional information based on the received surgicalinformation; and sending the obtained instructional information to theat least one smart surgical device.
 11. The method of claim 9, whereinthe instructional information comprises at least one of: an adjustmentto a surgical function; prioritization information; a cartridge usagerecommendation; a warning message; surgical device usagerecommendations; or surgical device usage instructions.
 12. The methodof claim 9, further comprising determining whether to disablecommunication with an external system based on the hub connectivitymode.
 13. The method of claim 9, further comprising determining whetherto send recorded surgical information associated with a procedure to theremote server based on the hub connectivity mode.
 14. The method ofclaim 9, further comprising receiving data from the remote server, andthe processor is further configured to: determining whether to retrieveaggregation analysis from the remote server based on the hubconnectivity mode; based on a determination to retrieve the aggregationanalysis, generating an aggregation analysis request based on thereceived surgical data; sending the aggregation analysis request to theremote server via the transmitter; receiving an aggregation analysisresponse from the remote server via the receiver; generating theinstructional information based on the aggregation analysis response;and sending the instructional information to the at least one smartdevice via the transmitter.
 15. The method of claim 9, wherein the hubconnectivity control parameter comprises at least one of: available databandwidth, power capacity associated with the surgical hub, powercapacity associated with an operating room, power capacity associatedwith a medical facility, a power usage, processor utilizationinformation, or memory utilization information.
 16. The method of claim9, wherein the hub connectivity control parameter comprises at least oneof: a subscription level associated with hub connectivity, a userpreference associated with hub connectivity, or an indication from atiered software control system.
 17. A computer readable mediumcomprising instructions stored therein, when executed performing:receiving surgical information from at least one smart surgical device;determining a hub connectivity mode based on a hub connectivity controlparameter; determining whether to send instructional information to theat least one smart device based on the hub connectivity mode; andcommunicating with the at least one smart device based on thedetermination.
 18. The computer readable medium of claim 17, furthercomprising instructions when executed performing: based on adetermination to send instructional information, obtaining instructionalinformation based on the received surgical information; and sending theobtained instructional information to the at least one smart surgicaldevice.
 19. The computer readable medium of claim 17, further comprisinginstructions when executed performing: determining whether to disablecommunication with an external system based on the hub connectivitymode.
 20. The computer readable medium of claim 17, further comprisinginstructions when executed performing: determining whether to sendrecorded surgical information associated with a procedure to the remoteserver based on the hub connectivity mode.